Product Code: HRS
FDA class 2
21 CFR 888.3030
Plate, Fixation, Bone
Orthopedic
A bone fixation plate is a metallic implant used in orthopedic surgery to stabilize and hold fractured or osteotomized bone segments in position during the healing process. It is classified as an FDA Class 2 device under 21 CFR 888.3030, indicating moderate risk and requiring 510(k) premarket clearance. Product code HRS falls under the Orthopedic medical specialty. This device is an implant.
510(k)s
1255
FEI Numbers
505
Registration Numbers
505
Unique Applicants
435
Years Active
49
Basic Information
- Product Code
- HRS
- Device Class
- FDA class 2
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✓
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 1255 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251945 | TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) | Jul 10, 2025 | Substantially Equivalent | TriMed, Inc. |
| K242988 | Genostis Osteosynthesis System | Jun 27, 2025 | Substantially Equivalent | Genostis AF |
| K250929 | TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Lag Screw 3.2mm) | Jun 26, 2025 | Substantially Equivalent | TriMed, Inc. |
| K243275 | Equinoxe® Scapula Fracture System | Jun 26, 2025 | Substantially Equivalent | Exactech, Inc |
| K250933 | LORRAINE 2.5/3.5mm Distal Humerus System | Jun 11, 2025 | Substantially Equivalent | Bonebridge AG |
| K243368 | Montblanc Plate System | Jun 04, 2025 | Substantially Equivalent | Medifield Medical Co., Ltd. |
| K242751 | ARIX Pectus Bar System | May 30, 2025 | Substantially Equivalent | Jeil Medical Corporation |
| K243469 | SIGNEX | May 29, 2025 | Substantially Equivalent | OSTEONIC Co., Ltd. |
| K250935 | TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw) | May 22, 2025 | Substantially Equivalent | TriMed, Inc. |
| K243963 | Pediatric Plating Platform Hip | Apr 29, 2025 | Substantially Equivalent | OrthoPediatrics Corp. |
| K250892 | CastleLoc Pectus Bar System | Apr 25, 2025 | Substantially Equivalent | L&K Biomed Co., Ltd. |
| K242973 | CanMINI Hand and Foot System | Apr 24, 2025 | Substantially Equivalent | CANWELL MEDICAL CO., LTD. |
| K250155 | Xpert Knee | Apr 23, 2025 | Substantially Equivalent | Newclip Technics |
| K250948 | TriMed Fusion Cup System | Apr 08, 2025 | Substantially Equivalent | TriMed, Inc. |
| K243995 | Arthrex Humeral Plating System and Cerclage Button | Mar 26, 2025 | Substantially Equivalent | Arthrex Inc. |
| K243999 | TriMed Ankle Fixation System | Mar 19, 2025 | Substantially Equivalent | TriMed, Inc. |
| K243987 | TriMed Elbow and Forearm System | Mar 19, 2025 | Substantially Equivalent | TriMed, Inc. |
| K242486 | Tyber Medical Anatomical Plating System | Mar 19, 2025 | Substantially Equivalent | Tyber Medical, LLC |
| K250494 | The OsteoCentric Bone Plate and Screw System | Mar 18, 2025 | Substantially Equivalent | OsteoCentric Technologies |
| K250498 | BPS Wrist Fracture System | Mar 17, 2025 | Substantially Equivalent | OrthoNovis, Inc. |
| K243610 | APTUS Hand System; APTUS Elbow Dorsal Olecranon | Mar 07, 2025 | Substantially Equivalent | Medartis AG |
| K243357 | CastleLoc Pectus Bar System | Feb 27, 2025 | Substantially Equivalent | L&K BIOMED Co., Ltd. |
| K243761 | A.L.P.S. Small Fragment Plating System | Feb 19, 2025 | Substantially Equivalent | Biomet Orthopedics |
| K241666 | EVOS Pelvic and Acetabular System | Feb 19, 2025 | Substantially Equivalent | Smith & Nephew |
| K240958 | Locking Plates and Screws Systems | Feb 10, 2025 | Substantially Equivalent | Hebei Ruihe Medical Devices Co., Ltd. |
| K250055 | BPS - Bone Fragment Fixation Plates, Screws and Washers | Feb 06, 2025 | Substantially Equivalent | OrthoNovis, Inc. |
| K241599 | Signature Osteosynthesis Plate System | Feb 06, 2025 | Substantially Equivalent | Signature Orthopaedic Pty Ltd. |
| K243740 | Versalock Upper Limb Plating System | Jan 29, 2025 | Substantially Equivalent | GM Dos Reis Industria e Comercio Ltda |
| K243569 | TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle Plates); TriMed Wrist Fixation System (Hook Plates); TriMed Wrist Fixation System (Pin Plates); TriMed Wrist Fixation System (Peg Plates); TriMed Wrist Fixation System (Shear Plates); TriMed Wrist Fixation System (Wireform plates and Washer); TriMed Wrist Fixation System (Wireforms); TriMed Wrist Fixation System (Torx Cortical Screws); TriMed Wrist Fixation System (Torx Threaded Pegs); | Jan 15, 2025 | Substantially Equivalent | TriMed, Inc. |
| K242939 | ARTFX Trauma Bone Plate and Screw System | Dec 23, 2024 | Substantially Equivalent | ARTFX Medical |
| K243308 | Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste) | Dec 20, 2024 | Substantially Equivalent | Bonebridge AG |
| K243491 | SternalPlate Expansion | Dec 11, 2024 | Substantially Equivalent | Stryker Leibinger GmbH & Co. KG |
| K241128 | TDM Plate and Screw System | Dec 05, 2024 | Substantially Equivalent | TDM Co., Ltd. |
| K243050 | TriMed Posterior Malleolus Fixation System | Nov 26, 2024 | Substantially Equivalent | TriMed, Inc. |
| K241995 | HyperFlex Bunion Correction System | Nov 26, 2024 | Substantially Equivalent | FootBridge Medical |
| K242998 | GMReis Ankle Plating System | Nov 21, 2024 | Substantially Equivalent | GM Dos Reis Industria e Comercio Ltda |
| K242596 | Versalock Mini and Micro Plating System | Nov 21, 2024 | Substantially Equivalent | GM Dos Reis Industria e Comercio Ltda |
| K242814 | Tandry Q-Locking Plate System | Nov 14, 2024 | Substantially Equivalent | Microware Precision Co., Ltd. |
| K242436 | Proximal Humerus Fixation System | Nov 14, 2024 | Substantially Equivalent | Skeletal Dynamics, Inc. |
| K242079 | Arthrex Elbow Fracture Plating System | Nov 14, 2024 | Substantially Equivalent | Arthrex Inc. |
| K240388 | Osteotomy Truss System (OTS) | Nov 01, 2024 | Substantially Equivalent | 4WEB Medical, Inc. |
| K242399 | Bonebridge Osteosynthesis Plating System | Oct 31, 2024 | Substantially Equivalent | Bonebridge AG |
| K242995 | OIC Small / Mini Fragment Plate System | Oct 23, 2024 | Substantially Equivalent | The Orthopaedic Implant Company |
| K242554 | Arthrex VAL and VAL KreuLock Compression Screw System | Oct 21, 2024 | Substantially Equivalent | Arthrex, Inc. |
| K240181 | Clavicle and Scapula System | Oct 09, 2024 | Substantially Equivalent | Auxein Medical Pvt. Ltd |
| K242445 | Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System | Oct 06, 2024 | Substantially Equivalent | Stryker GmbH |
| K242343 | BPS Wrist Fracture System | Oct 04, 2024 | Substantially Equivalent | OrthoNovis, Inc. |
| K241815 | Protean Fragment Plating System | Sep 26, 2024 | Substantially Equivalent | Skeletal Dynamics Inc |
| K241709 | Pectus Blu Support Bar System | Sep 19, 2024 | Substantially Equivalent | Biomet Microfixation |
| K241942 | TriMed Bridge Plates | Sep 17, 2024 | Substantially Equivalent | TriMed, Inc. |
| K241356 | Fine Osteotomy | Sep 05, 2024 | Substantially Equivalent | Bodycad Laboratories Inc. |
| K240487 | EVOS Patella Plates | Sep 03, 2024 | Substantially Equivalent | Smith & Nephew |
| K233816 | REDEMPTION Charcot Plating System | Aug 28, 2024 | Substantially Equivalent | Vilex, LLC |
| K240318 | SITTER 3.5mm Versatile System | Aug 23, 2024 | Substantially Equivalent | Bonebridge AG |
| K241282 | RibFix Titan Fixation System | Aug 19, 2024 | Substantially Equivalent | Riverpoint Medical |
| K241754 | NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate | Aug 15, 2024 | Substantially Equivalent | Zimmer Switzerland Manufacturing GmbH |
| K241387 | CoLink NeoFuse MIS Plating System (see attached parts list) | Aug 13, 2024 | Substantially Equivalent | In2Bones USA |
| K242055 | Freefix Forearm Plating System | Aug 01, 2024 | Substantially Equivalent | Skeletal Dynamics Inc |
| K241539 | Activmotion S | Jul 30, 2024 | Substantially Equivalent | Newclip Technics |
| K233994 | VOLT Proximal Humerus 3.5 Plating System | Jul 26, 2024 | Substantially Equivalent | Synthes GmbH |
| K241296 | Gaudi Proximal Humerus Plate | Jul 23, 2024 | Substantially Equivalent | Netbiologics, LLC |
| K241018 | KLS Martin Orthopedic Implants - MR Conditional | Jul 12, 2024 | Substantially Equivalent | KLS-Martin L.P. |
| K234059 | Forma Medical Optimal Plating System | Jun 26, 2024 | Substantially Equivalent | Forma Medical, Inc. |
| K232829 | Versalock Rib and Sternum Plates System | Jun 26, 2024 | Substantially Equivalent | GM Dos Reis Industria e Comercio Ltda |
| K240613 | APTUS Elbow Dorsal Olecranon Plates | Jun 20, 2024 | Substantially Equivalent | Medartis AG |
| K230546 | SIGNEX | Jun 11, 2024 | Substantially Equivalent | OSTEONIC Co., Ltd. |
| K241262 | Baby Gorilla/Gorilla Plating System; Monster Screw System | Jun 05, 2024 | Substantially Equivalent | Paragon 28, Inc. |
| K241218 | Tyber Medical Anatomical Plating System | May 31, 2024 | Substantially Equivalent | Tyber Medical, LLC |
| K233089 | NeoSpan® Compression Implant System | May 24, 2024 | Substantially Equivalent | In2Bones USA, LLC |
| K233967 | DePuy Synthes MatrixSTERNUM Fixation System | May 09, 2024 | Substantially Equivalent | Synthes GmbH |
| K233873 | XLO Brand of Locking Distal Humerus Plating System | Apr 26, 2024 | Substantially Equivalent | Ortho Life Systems Private Limited |
| K233311 | Acumed Wrist Plating System | Apr 22, 2024 | Substantially Equivalent | Acumed LLC |
| K232105 | APTUS Foot System 2.8-3.5 | Apr 19, 2024 | Substantially Equivalent | Medartis AG |
| K233863 | TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate), TriMed ASET Foot Plating System (H-Plate), TriMed ASET Foot Plating System (Talonavicular Plate), TriMed ASET Foot Plating System (Calcaneal Slide Osteotomy Plate), TriMed ASET Foot Plating System (Evans Osteotomy Plate), TriMed ASET Foot Plating System (Medial Column Fusion Plate), TriMed ASET Foot Plating System (Straight Plate), TriMed ASET Foot Plating System (T- | Apr 17, 2024 | Substantially Equivalent | TriMed, INC |
| K240703 | Fine Osteotomy | Apr 12, 2024 | Substantially Equivalent | BodyCad Laboratories, Inc. |
| K232115 | TDM Large Bone Plate and Screw System | Apr 05, 2024 | Substantially Equivalent | TDM CO., LTD |
| K233919 | VariAx 2 Distal Radius System | Mar 25, 2024 | Substantially Equivalent | Stryker GmbH |
| K234062 | APTUS Hand Scaphoid Plates | Mar 21, 2024 | Substantially Equivalent | Medartis AG |
| K233665 | DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System | Mar 21, 2024 | Substantially Equivalent | DePuy Synthes |
| K240173 | Treace Medical Systems (TMC) Plating System | Feb 22, 2024 | Substantially Equivalent | Treace Medical Concepts Inc. |
| K231213 | HKT Anatomical Locking Trauma System | Jan 19, 2024 | Substantially Equivalent | Hankil Tech Medical Co., Ltd |
| K234031 | Medline UNITE Ancillary Foot Recon Plating System | Jan 18, 2024 | Substantially Equivalent | Medline Industires, LP |
| K231684 | Quick - Radius Disposable Set | Jan 12, 2024 | Substantially Equivalent | GM Dos Reis Industria e Comercio Ltda |
| K233423 | Tyber Medical Anatomical Plating System Line extension to the Mini-Frag System | Dec 21, 2023 | Substantially Equivalent | Tyber Medical, LLC. |
| K233154 | SkyOPS Orthopedic Plate System | Dec 21, 2023 | Substantially Equivalent | Sky Surgical LLC |
| K233017 | TM Plating System | Dec 20, 2023 | Substantially Equivalent | Tyber Medical, LLC. |
| K232394 | Internal Locking Plate and Screw Fixation System | Dec 15, 2023 | Substantially Equivalent | Changzhou Geasure Medical Apparatus and Instruments Co., Ltd |
| K231887 | ARIX Ankle Distal Tibia System | Dec 14, 2023 | Substantially Equivalent | Jeil Medical Corporation |
| K232652 | Anatomical Plating System (various) | Dec 13, 2023 | Substantially Equivalent | Tyber Medical, LLC. |
| K232515 | Valkyrie Thoracic Fixation System | Dec 08, 2023 | Substantially Equivalent | JM Longyear Manufacturing, LLC d/b/a Able Medical Devices |
| K232693 | Tyber Medical Distal Radius Plating System | Dec 04, 2023 | Substantially Equivalent | Tyber Medical, LLC. |
| K230591 | TriLEAP Plating System | Sep 29, 2023 | Substantially Equivalent | CrossRoads Extremity Systems |
| K223933 | Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws | Sep 25, 2023 | Substantially Equivalent | Exactech, Inc |
| K230805 | TriMed Clavicle Fixation System | Sep 01, 2023 | Substantially Equivalent | TriMed, Inc. |
| K230623 | KITE Distal Fibula Kit | Sep 01, 2023 | Substantially Equivalent | Intrauma S.p.A |
| K231623 | Distal Elbow Plating System | Aug 28, 2023 | Substantially Equivalent | Skeletal Dynamics Inc |
| K223150 | APS Metal Plate & Screw System | Aug 24, 2023 | Substantially Equivalent | A Plus Biotechnology Co., Ltd |
| K232144 | Sterile Products of the APTUS System | Aug 18, 2023 | Substantially Equivalent | Medartis AG |
| K231262 | Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System | Aug 18, 2023 | Substantially Equivalent | Stryker GmbH |
| K231257 | Pangea Utility Plating System, Pangea Platform | Aug 18, 2023 | Substantially Equivalent | Stryker GmbH |
| K230690 | Tandry Locking Plate System | Aug 17, 2023 | Substantially Equivalent | Microware Precision Co., Ltd. |
| K231292 | TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System | Jul 19, 2023 | Substantially Equivalent | Bonebridge AG |
| K231441 | ARIX Ankle System | Jul 17, 2023 | Substantially Equivalent | Jeil Medical Corporation |
| K230971 | APTUS® 3.5 TriLock Straight Plates | Jun 02, 2023 | Substantially Equivalent | Medartis AG |
| K223762 | Smith & Nephew ACCORD Cable System | May 30, 2023 | Substantially Equivalent | Smith & Nephew |
| K222624 | KLS Martin LINOS Wrist System | May 25, 2023 | Substantially Equivalent | KLS-Martin L.P. |
| K230938 | ARIX Humerus System | May 03, 2023 | Substantially Equivalent | Jeil Medical Corporation |
| K222381 | PeriPRO Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System | Apr 27, 2023 | Substantially Equivalent | Stryker GmbH |
| K230204 | ALPHALOK Plating System | Apr 25, 2023 | Substantially Equivalent | Vilex LLC |
| K223772 | PRO Plating System, Stryker Trauma Pelvic Set (Matta) | Apr 07, 2023 | Substantially Equivalent | Stryker GMbH |
| K223853 | Medartis APTUS® Ulna Plates | Mar 30, 2023 | Substantially Equivalent | Medartis AG |
| K223342 | MotoBAND CP Implant System: DynaBunion 4D Minimal-incision Bunion System, DynaMET Lesser TMT Fusion System | Mar 30, 2023 | Substantially Equivalent | CrossRoads Extremity Systems, LLC |
| K230527 | WishBone Medical Plate and Screw System | Mar 29, 2023 | Substantially Equivalent | WishBone Medical, Inc. |
| K222397 | KLS Martin Level One Rib Fixation System | Mar 29, 2023 | Substantially Equivalent | KLS-Martin L.P. |
| K221938 | KLS Martin Pure Pectus System | Mar 28, 2023 | Substantially Equivalent | KLS Martin L.P. |
| K230141 | LOQTEQ® VA Elbow Plates 2.7/3.5 System | Mar 17, 2023 | Substantially Equivalent | aap Implantate AG |
| K222465 | Tyber Medical Anatomical Plating System | Mar 07, 2023 | Substantially Equivalent | Tyber Medical, LLC |
| K213059 | Tibia and Fibula System | Jan 27, 2023 | Substantially Equivalent | Auxein Medical Private Limited |
| K222665 | Medline UNITE® Ankle Fusion Plating System | Jan 25, 2023 | Substantially Equivalent | Medline Industries, Inc. |
| K221150 | Advanced Bone Plate | Jan 25, 2023 | Substantially Equivalent | Double Medical Technology Inc. |
| K223118 | OIC Variable Angle Small Fragment Locking Plate System | Jan 21, 2023 | Substantially Equivalent | Orthopaedic Implant Company |
| K221088 | Anatomic Bone Plate | Jan 18, 2023 | Substantially Equivalent | Double Medical Technology Inc. |
| K221181 | Treace Medical Concepts (TMC) Plating System | Jan 05, 2023 | Substantially Equivalent | Treace Medical Concepts Inc. |
| K222637 | TriMed Wrist Fixation System 3 | Dec 21, 2022 | Substantially Equivalent | TriMed, Inc. |
| K221412 | ARIX Rib System | Nov 22, 2022 | Substantially Equivalent | Jeil Medical Corporation |
| K221558 | ALPHALOK Plating System | Nov 15, 2022 | Substantially Equivalent | Vilex LLC |
| K213108 | Humerus & Ulna System | Nov 04, 2022 | Substantially Equivalent | Auxein Medical Private Limited |
| K222282 | HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System | Oct 27, 2022 | Substantially Equivalent | Hospital Equipment Manufacturing Company |
| K213123 | EVOS Wrist Spanning Plate | Oct 18, 2022 | Substantially Equivalent | Smith & Nephew, Inc. |
| K222267 | Arthrex 2.4 mm Volar Distal Radius Plate System | Oct 03, 2022 | Substantially Equivalent | Arthrex Inc. |
| K213014 | Varixis Elbow System | Oct 03, 2022 | Substantially Equivalent | Auxein Medical Private Limited |
| K222244 | Arthrex 3.5 mm Locking Compression Plates | Sep 30, 2022 | Substantially Equivalent | Arthrex Inc. |
| K221360 | Medline UNITE® Medial Malleolus Peg Plate System | Sep 27, 2022 | Substantially Equivalent | Medline Industries, LP |
| K221809 | DePuy Synthes 3.5mm Intrapelvic Acetabular System | Sep 20, 2022 | Substantially Equivalent | DePuy Synthes |
| K213864 | Bonebridge Osteosynthesis Plating System | Sep 02, 2022 | Substantially Equivalent | Bonebridge AG |
| K210935 | I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) | Aug 31, 2022 | Substantially Equivalent | I.T.S. GmbH |
| K221920 | ARIX Small Fragment System | Aug 24, 2022 | Substantially Equivalent | Jeil Medical Corporation |
| K222194 | Baby Gorilla®/Gorilla® Plating System | Aug 19, 2022 | Substantially Equivalent | Paragon 28, Inc. |
| K221346 | Stryker VariAx 2 MIS Calcaneus | Jul 08, 2022 | Substantially Equivalent | Stryker GmbH |
| K221395 | Footmotion Plating System | Jul 01, 2022 | Substantially Equivalent | Newclip Technics |
| K220937 | Arthrex Mini Fragment System | Jun 29, 2022 | Substantially Equivalent | Arthrex Inc. |
| K221465 | Baby Gorilla/Gorilla Plating System | Jun 17, 2022 | Substantially Equivalent | Paragon 28, Inc. |
| K221362 | Omni Foot and Ankle Plating System | Jun 10, 2022 | Substantially Equivalent | Exremity Medical, LLC. |
| K213698 | CoLink PCR Plating System | May 27, 2022 | Substantially Equivalent | In2Bones USA, LLC |
| K212979 | CalcShift Displacement Calcaneal Osteotomy System | May 20, 2022 | Substantially Equivalent | Nextremity Solutions, Inc. |
| K220463 | Osteotomy Truss System (OTS) | May 18, 2022 | Substantially Equivalent | 4WEB Medical, Inc. |
| K212782 | SternaLock Sternal Closure System | May 17, 2022 | Substantially Equivalent | Biomet Microfixation |
| K213837 | Arthrx Fracture Plates | May 02, 2022 | Substantially Equivalent | Arthrex Inc. |
| K212348 | ALPHALOK Plating System | May 02, 2022 | Substantially Equivalent | Vilex LLC |
| K220244 | DVR® Crosslock Wrist Spanning Plate (131849181) | Apr 28, 2022 | Substantially Equivalent | Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech |
| K212608 | RibFix Blu Thoracic Fixation System | Apr 22, 2022 | Substantially Equivalent | Biomet Microfixation |
| K212601 | DRPx Locking Distal Radius Plate System | Apr 05, 2022 | Substantially Equivalent | Orthopaedic Implant Company |
| K220199 | AFFINITY Proximal Tibia System | Mar 21, 2022 | Substantially Equivalent | Techfit Digital Surgery INC. |
| K211324 | 2.4mm Distal Radius System | Mar 14, 2022 | Substantially Equivalent | Auxein Medical Private Limited |
| K213712 | Pectus Support Bar System | Mar 11, 2022 | Substantially Equivalent | Biomet Microfixation |
| K213005 | Apollo Ankle Fracture Plating System | Mar 11, 2022 | Substantially Equivalent | GLW Medical Inc |
| K201229 | Intai Anatomic Locking Plate and Screw System | Mar 11, 2022 | Substantially Equivalent | Intai Technology Corporation |
| K211843 | PolyLock Plating System | Mar 04, 2022 | Substantially Equivalent | Fusion Orthopedics |
| K213567 | Medline UNITE Calcaneal Fracture Plating System | Mar 02, 2022 | Substantially Equivalent | Medline Industries, LP |
| K212378 | Arsenal Ankle Plating System | Feb 23, 2022 | Substantially Equivalent | Trilliant Surgical |
| K201510 | Traufix osteosynthesis, osteotomy, and arthrodesis devices | Feb 18, 2022 | Substantially Equivalent | Fixier, S.A. de C.V. |
| K220136 | Treace Medical Concepts (TMC) Plating System | Feb 16, 2022 | Substantially Equivalent | Treace Medical Concepts, Inc. |
| K212545 | FlexitSystem Knee osteotomy system | Feb 11, 2022 | Substantially Equivalent | Neosteo |
| K213489 | Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate | Jan 27, 2022 | Substantially Equivalent | WishBone Medical, Inc. |
| K213591 | ANTHEM® Fracture System | Jan 26, 2022 | Substantially Equivalent | Globus Medical Inc. |
| K202914 | SternaFuse Fixation System | Jan 26, 2022 | Substantially Equivalent | Fusion Innovations, LLC |
| K212581 | VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System | Jan 19, 2022 | Substantially Equivalent | Stryker GmbH |
| K213895 | Distal Humerus Plating System | Jan 13, 2022 | Substantially Equivalent | Skeletal Dynamics, Inc. |
| K212841 | Pectus Blu Support Bar System | Jan 07, 2022 | Substantially Equivalent | Biomet Micofixation |
| K210198 | GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes, GPC 2.4mm Variable Angle Locking Two Column Volar Distal Radius Plates, 7 Head Holes, 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plate-Narrow, 6 Head Holes, Variable Angle Locking Screw 2.4 mm, Stardrive | Jan 07, 2022 | Substantially Equivalent | GPC Medical Limited |
| K202803 | Activmotion S DTO | Dec 16, 2021 | Substantially Equivalent | Newclip Technics |
| K213069 | CoLink NeoFuse Plating System | Dec 13, 2021 | Substantially Equivalent | In2Bones USA, LLC |
| K213214 | Xpert Wrist | Nov 24, 2021 | Substantially Equivalent | Newclip Technics |
| K211650 | The Radian MIS Bunion System | Nov 24, 2021 | Substantially Equivalent | Nvision Biomedical Technologies, Inc |
| K212640 | Stratum® Ankle Fusion Plating System | Nov 18, 2021 | Substantially Equivalent | Nextremity Solutions, Inc. |
| K212487 | CoLink Vallux Plating System | Nov 18, 2021 | Substantially Equivalent | In2Bones USA, LLC |
| K211582 | LOQTEQ Proximal Humerus Plate 3.5 System | Oct 18, 2021 | Substantially Equivalent | aap Implantate AG |
| K203002 | SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, TAMlNA 3.5mm Proximal Humerus System, TRIFT 3.5mm 1/3 Tubular System | Oct 05, 2021 | Substantially Equivalent | Bonebridge AG |
| K212433 | Anthem Fracture System | Oct 01, 2021 | Substantially Equivalent | Globus Medical Inc. |
| K212334 | GEO Extremity and Ankle Plating System | Sep 21, 2021 | Substantially Equivalent | Gramercy Extremity Orthopedics, LLC |
| K212297 | Omni Foot and Ankle Plating System | Aug 20, 2021 | Substantially Equivalent | Extremity Medical, LLC. |
| K203817 | Tyber Medical Anatomical Plating System | Aug 13, 2021 | Substantially Equivalent | Tyber Medical LLC |
| K203408 | Summit Patella Plating System | Jul 30, 2021 | Substantially Equivalent | Endeavor Orthopaedics, LLC |
| K211646 | FINE Osteotomy | Jul 28, 2021 | Substantially Equivalent | Bodycad Laboratories, Inc. |
| K210016 | Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System | Jul 27, 2021 | Substantially Equivalent | Integra Lifesciences Corporation |
| K211592 | Avanti Orthopaedics Ulnar Shortening System | Jul 16, 2021 | Substantially Equivalent | Avanti Orthopaedics, Inc. |
| K210750 | Acumed Clavicle Hook Plating System | Jul 15, 2021 | Substantially Equivalent | Acumed LLC |
| K200575 | TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM | Jul 09, 2021 | Substantially Equivalent | TRUEMED GROUP LLC |
| K210837 | Smith & Nephew Plates and Screws | Jun 29, 2021 | Substantially Equivalent | Smith & Nephew, Inc. |
| K211695 | Valkyrie Thoracic Fixation System | Jun 23, 2021 | Substantially Equivalent | JM Longyear Manufacturing, LLC d/b/a Able Medical Devices |
| K211051 | DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System) | Jun 02, 2021 | Substantially Equivalent | DePuy Synthes |
| K202971 | DRPx Locking Distal Radius Plate System | May 06, 2021 | Substantially Equivalent | Orthopaedic Implant Company |
| K210290 | JACE Medical Thoracic Plating System | Apr 30, 2021 | Substantially Equivalent | JACE Medical, LLC |
| K210157 | SOLE Medial Column Fusion Plate | Apr 20, 2021 | Substantially Equivalent | Orthofix SRL |
| K210658 | Volition Plating System | Apr 13, 2021 | Substantially Equivalent | Ortho Solutions UK Ltd |
| K210408 | DePuy Synthes Variable Angle Locking Patella Plating System | Apr 08, 2021 | Substantially Equivalent | Synthes (USA) Products, LLC |
| K210534 | GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System | Mar 26, 2021 | Substantially Equivalent | Gramercy Extremity Orthopedics, LLC |
| K210205 | DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System | Mar 26, 2021 | Substantially Equivalent | Synthes (USA) products, LLC |
| K203834 | Arthrex Patella SuturePlates | Mar 25, 2021 | Substantially Equivalent | Arthrex Inc. |
| K210060 | CoLink Mfx Implant System | Mar 12, 2021 | Substantially Equivalent | In2Bones USA, LLC |
| K201728 | Versalock Periprosthetic Femur Plates System-GMReis | Mar 08, 2021 | Substantially Equivalent | GM dos Reis Industria e Comercio Ltda |
| K210043 | LOQTEQ Distal Lateral Femur Plate 4.5 System | Mar 03, 2021 | Substantially Equivalent | AAP Implantate AG |
| K202889 | Able Medical Devices Valkyrie Thoracic Fixation System | Mar 02, 2021 | Substantially Equivalent | JM Longyear Manufacturing, LLC D.B.A. Able Medical Devices |
| K203479 | ExtremiLOCK Lateral Ankle Fusion Plates | Feb 24, 2021 | Substantially Equivalent | OsteoMed |
| K200062 | Foot and Ankle System | Feb 22, 2021 | Substantially Equivalent | Leith Medical LLC |
| K210192 | A.L.P.S. Clavicle Plating System | Feb 19, 2021 | Substantially Equivalent | Biomet Inc. |
| K203294 | Arthrex Pilon Fusion System | Feb 03, 2021 | Substantially Equivalent | Arthrex Inc. |
| K203474 | Biomet Microfixation RibFix Advantage System | Jan 28, 2021 | Substantially Equivalent | Biomet Micofixation |
| K203405 | EVOS Large Fragment Plating System | Jan 27, 2021 | Substantially Equivalent | Smith & Nephew, Inc. |
| K201259 | ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System | Jan 08, 2021 | Substantially Equivalent | Wright Medical Technology, Inc. |
| K203511 | Baby Gorilla/Gorilla Plating System | Dec 29, 2020 | Substantially Equivalent | Paragon 28, Inc. |
| K203414 | DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System | Dec 16, 2020 | Substantially Equivalent | DePuy Synthes |
| K202657 | Javelin Tailor's Bunion Fixation System | Dec 14, 2020 | Substantially Equivalent | Nvision Biomedical Technologies, Inc |
| K202959 | PolyLock Plating System | Nov 24, 2020 | Substantially Equivalent | Fusion Orthopedics, LLC |
| K202764 | Ortho Solutions Plating System | Nov 20, 2020 | Substantially Equivalent | Ortho Solutions UK Ltd |
| K202307 | Activ Fuse | Nov 17, 2020 | Substantially Equivalent | Newclip Technics |
| K201918 | EVOS Large Fragment Plating System | Nov 16, 2020 | Substantially Equivalent | Smith & Nephew, Inc. |
| K202912 | ARIX Ankle Distal Tibia System | Oct 29, 2020 | Substantially Equivalent | Jeil Medical Corporation |
| K202496 | ANTHEM Fracture System | Oct 29, 2020 | Substantially Equivalent | Globus Medical Inc. |
| K202489 | AOS Fibonacci Lower Extremity Plating System AOS Proximal Tibia Plating System | Oct 26, 2020 | Substantially Equivalent | Advanced Orthopaedic Solutions, Inc. |
| K201962 | Skeletal Dynamics Ulnar Shortening Plating System | Oct 13, 2020 | Substantially Equivalent | Skeletal Dynamics, Inc. |
| K201917 | Piccolo Composite Proximal Tibia Plate System | Oct 08, 2020 | Substantially Equivalent | CarboFix Orthopedics, Ltd. |
| K201656 | ARIX Elbow System | Sep 15, 2020 | Substantially Equivalent | Jeil Medical Corporation |
| K201959 | DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System | Sep 11, 2020 | Substantially Equivalent | DePuy Synthes |
| K201578 | DePuy Synthes Variable Angle Locking Patella Plating System | Sep 09, 2020 | Substantially Equivalent | Synthes (USA) Products, LLC |
| K201677 | Arthrex Mesh Plates | Sep 02, 2020 | Substantially Equivalent | Arthrex Inc. |
| K201132 | Arthrex Compression Screws | Jul 27, 2020 | Substantially Equivalent | Arthrex Inc. |
| K200785 | Stratum Reduced Size Foot Plating System | Jul 27, 2020 | Substantially Equivalent | Nextremity Solutions, Inc. |
| K201321 | DePuy Synthes 2.7mm VA LCP Clavicle Plate System | Jul 24, 2020 | Substantially Equivalent | DePuy Synthes |
| K201527 | EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm) | Jul 22, 2020 | Substantially Equivalent | Smith & Nephew, Inc. |
| K200513 | DAC Dynamic Active Compression Plate | Jul 22, 2020 | Substantially Equivalent | Pioneer Surgical Technology, Inc., DBA RTI Surgical |
| K201149 | CoLink Plating System | Jul 15, 2020 | Substantially Equivalent | In2Bones USA, LLC |
| K193345 | Arthrex DynaNite Compression Plate | Jul 08, 2020 | Substantially Equivalent | Arthrex Inc. |
| K201235 | Arthrex MaxForce MTP Compression Plates and Screws | Jul 06, 2020 | Substantially Equivalent | Arthrex Inc. |
| K200834 | Lever Action Plate System | Jun 25, 2020 | Substantially Equivalent | McGinley Orthpaedic Innovations, LLC |
| K200398 | AxSOS 3 AF System and AxSOS 3 Ti System | Jun 05, 2020 | Substantially Equivalent | Stryker GmbH |
| K200538 | Skeletal Dynamics Forearm Plating System | Jun 01, 2020 | Substantially Equivalent | Skeletal Dynamics, Inc. |
| K200246 | JPS JuniOrtho Plating System | May 22, 2020 | Substantially Equivalent | Orthofix Srl |
| K200701 | Skeletal Dynamics Midshaft Humerus Plating System | May 14, 2020 | Substantially Equivalent | Skeletal Dynamics, Inc. |
| K200367 | Distal Humerus Plating System | May 14, 2020 | Substantially Equivalent | Skeletal Dynamics, Inc. |
| K200961 | Treace Medical Concepts (TMC) Plating System | May 08, 2020 | Substantially Equivalent | Treace Medical Concepts, Inc. |
| K200762 | CoLink Cfx Plating System | Apr 23, 2020 | Substantially Equivalent | In2Bones USA, LLC |
| K191867 | ATLAS Plating System | Apr 09, 2020 | Substantially Equivalent | MiRus, LLC |
| K200108 | GEO 1st MTP Joint Arthrodesis Plating System | Mar 26, 2020 | Substantially Equivalent | Gramercy Extremity Orthopedics, LLC |
| K193639 | APTUS® Foot 2.8-3.5 System | Mar 26, 2020 | Substantially Equivalent | Medartis AG |
| K193633 | APTUS® Ankle Trauma System 2.8/3.5 | Mar 26, 2020 | Substantially Equivalent | Medartis AG |
| K193614 | FINE Osteotomy around the knee | Mar 25, 2020 | Substantially Equivalent | Bodycad Laboratories, Inc. |
| K200043 | Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range | Mar 23, 2020 | Substantially Equivalent | Field Orthopaedics Pty Ltd |
| K191057 | Park's Pectus System | Mar 19, 2020 | Substantially Equivalent | TDM Co. Ltd. |
| K193616 | ARIX Ankle System | Mar 04, 2020 | Substantially Equivalent | Jeil Medical Corporation |
| K192619 | Pitkar Locked Plating System | Feb 27, 2020 | Substantially Equivalent | S H Pitkar Orthotools Pvt Ltd. |
| K193554 | APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System | Feb 16, 2020 | Substantially Equivalent | Medartis AG |
| K190842 | Comus Locking Plate systems | Feb 03, 2020 | Substantially Equivalent | Jiangsu Trauhui Medical Instrument Co.,Ltd. |
| K192984 | APTUS Clavicle System | Jan 24, 2020 | Substantially Equivalent | Medartis AG |
| K193222 | Tyber Medical Anatomical Plating System | Jan 20, 2020 | Substantially Equivalent | Tyber Medical LLC |
| K193543 | CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System | Jan 17, 2020 | Substantially Equivalent | In2Bones USA, LLC |
| K193452 | MotoBAND CP Implant System | Jan 10, 2020 | Substantially Equivalent | CrossRoads Extemity Systems, LLC |
| K192696 | TriMed ASET Foot Plating System | Jan 05, 2020 | Substantially Equivalent | TriMed, Inc. |
| K182718 | Mini and Micro Fragments Reconstruction System GMReis | Dec 23, 2019 | Substantially Equivalent | Gm Dos Reis Industria E Comerico Ltda. |
| K192356 | Airlock Centrolock Osteosynthesis Implant System | Dec 14, 2019 | Substantially Equivalent | NOVASTEP |
| K191118 | Avanti Distal Radius and Forearm System | Dec 13, 2019 | Substantially Equivalent | Avanti Orthopaedics, Inc. |
| K191793 | Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System | Dec 09, 2019 | Substantially Equivalent | Nebula Surgical Private Limited |
| K192473 | Exsomed Wrist Plating System | Dec 03, 2019 | Substantially Equivalent | Exsomed Corporation |
| K192675 | VariAx Foot | Nov 22, 2019 | Substantially Equivalent | Stryker GmbH |
| K192592 | Axis Plating System | Nov 21, 2019 | Substantially Equivalent | Extremity Medical, LLC. |
| K192323 | PolyLock Small Bone Plating System | Nov 18, 2019 | Substantially Equivalent | Fusion Orthopedics, LLC |
| K190391 | TDM Plate and Screw Systems | Nov 15, 2019 | Substantially Equivalent | TDM Co. Ltd. |
| K191972 | ARIX Wrist System | Nov 12, 2019 | Substantially Equivalent | Jeil Medical Corporation |
| K192297 | APTUS Wrist Arthrodesis Plates | Nov 08, 2019 | Substantially Equivalent | Medartis AG |
| K192327 | DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile | Nov 07, 2019 | Substantially Equivalent | Synthes (USA) Products LLC |
| K192504 | Treace Medical Concepts (TMC) Plating System | Oct 30, 2019 | Substantially Equivalent | Treace Medical Concepts, Inc. |
| K190953 | Arthrex Minimally Invasive Ankle Fusion Plate | Oct 16, 2019 | Substantially Equivalent | Arthrex, Inc. |
| K191326 | Arthrex Mini Comprehensive Fixation System 1.4mm & 1.6mm Module | Oct 15, 2019 | Substantially Equivalent | Arthrex Inc. |
| K191344 | Arthrex Mini Comprehensive Fixation System 2.0mm & 2.4mm Module | Oct 03, 2019 | Substantially Equivalent | Arthrex Inc. |
| K191848 | APTUS Wrist Spanning Plates 2.5 | Sep 30, 2019 | Substantially Equivalent | Medartis AG |
| K191641 | AFFINITY Variable Angle Distal Radius System, AFFINITY Variable Angle Distal Radius Plates, AFFINITY Variable Angle Distal Radius Screws | Sep 16, 2019 | Substantially Equivalent | Industrias Medicas Sampedro S.A.S |
| K192217 | NCB Plating System Distal Femur and Proximal Tibia | Sep 13, 2019 | Substantially Equivalent | Zimmer GmbH |
| K191412 | VariAx 2 System, VariAx 2 Mini Fragment System | Aug 23, 2019 | Substantially Equivalent | Stryker GmbH |
| K192021 | NCB Polyaxial Locking Plate System | Aug 22, 2019 | Substantially Equivalent | Zimmer GmbH |
| K191009 | Arsenal Plating System | Aug 12, 2019 | Substantially Equivalent | Trilliant Surgical |
| K190385 | CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System | Aug 08, 2019 | Substantially Equivalent | In2Bones USA, LLC |
| K190992 | OrthoPediatrics PediFoot Deformity Corrections System | Aug 06, 2019 | Substantially Equivalent | OrthoPediatrics, Corp |
| K182818 | LOQTEQ VA Calcaneus Plate 3.5 | Aug 01, 2019 | Substantially Equivalent | aap Implantate AG |
| K191535 | CoLink® Mini Plating System | Jul 29, 2019 | Substantially Equivalent | In2Bones USA, LLC |
| K190963 | DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional | Jul 23, 2019 | Substantially Equivalent | Synthes (USA) Products LLC |
| K191711 | ORTHOLOC SPS Shoulder Plating System | Jul 17, 2019 | Substantially Equivalent | Tornier Inc. |
| K190750 | DePuy Synthes Plates and Screws Portfolio | Jun 21, 2019 | Substantially Equivalent | DePuy Synthes |
| K182785 | LOQTEQ VA Foot Plates 2.5 | Jun 19, 2019 | Substantially Equivalent | aap Implantate AG |
| K182650 | Arzzt Distal Radius and Ulna System | Jun 10, 2019 | Substantially Equivalent | Truemed Group LLC |
| K190388 | RIVAL View Plating Systems and Reduce Fracture Plating Systems | Jun 07, 2019 | Substantially Equivalent | Orthofix Srl |
| K183620 | PROSTEP TBC Implant System | Jun 06, 2019 | Substantially Equivalent | Wright Medical Technology, Inc. |
| K190670 | ORTHOLOC 2 Lapidus with Rotation System | May 14, 2019 | Substantially Equivalent | Wright Medical Technology, Inc. |
| K190409 | MatrixRIB Fixation System | May 03, 2019 | Substantially Equivalent | DePuy Synthes |
| K190415 | ATLAS Plating System | Apr 19, 2019 | Substantially Equivalent | MiRus, LLC |
| K190658 | MIS Bunion Plating System | Apr 12, 2019 | Substantially Equivalent | CrossRoads Extremity Systems, LLC |
| K190365 | Baby Gorilla/Gorilla Plating System | Apr 12, 2019 | Substantially Equivalent | Paragon 28, Inc. |
| K190253 | EVOS Small Fragment Upper Extremity Plates Line Additions | Mar 11, 2019 | Substantially Equivalent | Smith & Nephew, Inc |
| K183172 | Stryker SternalPlate System | Mar 05, 2019 | Substantially Equivalent | Stryker |
| K181843 | MLP Special Locking Bone Plate System | Mar 04, 2019 | Substantially Equivalent | Maxxion Medical, LLC / Baumer SA |
| K181872 | MIS Bunion System | Feb 19, 2019 | Substantially Equivalent | CrossRoads Extremity Systems, LLC |
| K183317 | AdvantageRib System | Feb 14, 2019 | Substantially Equivalent | SIG Medical Corporation |
| K182991 | EPIC Extremity Fusion Plate System | Feb 13, 2019 | Substantially Equivalent | EPIC Extremity, LLC |
| K183321 | Treace Medical Concepts (TMC) Plating System | Jan 25, 2019 | Substantially Equivalent | Treace Medical Concepts, Inc. |
| K183011 | Additive Orthopaedics Patient Specific 3D Locking Lattice Plates | Jan 10, 2019 | Substantially Equivalent | Additive Orthopaedics |
| K182783 | DePuy Synthes Trauma Orthopedic Nail Implants | Dec 26, 2018 | Substantially Equivalent | DePuy Synthes |
| K180821 | TruMatch Graft Cage - Long Bone | Dec 21, 2018 | Substantially Equivalent | Synthes (USA) LLC |
| K182810 | Distal Radius Plating System | Dec 10, 2018 | Substantially Equivalent | Miami Device Solutions, LLC |
| K181806 | ARIX Sternal System | Nov 20, 2018 | Substantially Equivalent | Jeil Medical Corporation |
| K182201 | Stratum Foot Plating System | Nov 16, 2018 | Substantially Equivalent | Nextremity Solutions, Inc. |
| K182179 | AdvantageRib Anterior System | Nov 16, 2018 | Substantially Equivalent | SIG Medical Corp. |
| K181820 | Medline Unite Mini Plates and Screws | Nov 01, 2018 | Substantially Equivalent | Medline Industries, Inc. |
| K180310 | DePuy Synthes Trauma Orthopedic Plates and Screws | Nov 01, 2018 | Substantially Equivalent | Synthes (USA) Products LLC/DePuy Orthopaedics Inc |
| K182466 | AOS Calcaneal Plating System | Oct 30, 2018 | Substantially Equivalent | Advanced Orthopaedic Solutions |
| K180554 | ANTHEM Fracture System | Oct 22, 2018 | Substantially Equivalent | Globus Medical Inc. |
| K180213 | Titanium TomoFix Medial High Tibia Plate Anatomical | Oct 19, 2018 | Substantially Equivalent | Synthes (USA) Products, LLC |
| K182015 | Piccolo Composite® Plate System | Oct 11, 2018 | Substantially Equivalent | CarboFix Orthopedics Ltd. |
| K181091 | AxSOS 3 Ti | Oct 11, 2018 | Substantially Equivalent | Stryker GmbH |
| K182492 | Geminus Volar Distal Radius Plate System | Oct 10, 2018 | Substantially Equivalent | Skeletal Dynamics, LLC |
| K181587 | ORTHOLOC SPS Shoulder Plating System | Oct 05, 2018 | Substantially Equivalent | Tornier Inc. |
| K180736 | WishBone Medical Plate and Screw System | Oct 04, 2018 | Substantially Equivalent | WishBone Medical, Inc. |
| K180972 | ARIX Clavicle System | Oct 03, 2018 | Substantially Equivalent | Jeil Medical Corporation |
| K182402 | CoLink View Plating System | Sep 27, 2018 | Substantially Equivalent | In2Bones USA, LLC |
| K171904 | Tandry Locking Plate System | Sep 18, 2018 | Substantially Equivalent | Microware Precision Co., Ltd. |
| K181035 | AOS Small Fragment Plating System Lite | Aug 24, 2018 | Substantially Equivalent | Advanced Orthopaedic Solutions, Inc. (AOS) |
| K181009 | APTUS CMC-I Fusion Plate System | Aug 24, 2018 | Substantially Equivalent | Medartis AG |
| K181533 | EVOS Wrist Fracture Plating System | Aug 09, 2018 | Substantially Equivalent | Smith & Nephew, Inc. |
| K181425 | APTUS® Proximal Humerus System | Aug 05, 2018 | Substantially Equivalent | Medartis AG |
| K180150 | PL8 Wrist Reconstruction Plate | Aug 02, 2018 | Substantially Equivalent | CITIEFFE S.r.l. |
| K181113 | CoLink Afx Plating System | Jun 15, 2018 | Substantially Equivalent | In2Bones USA, LLC |
| K181067 | AlignX Ankle Fusion System | May 23, 2018 | Substantially Equivalent | Extremity Medical, LLC |
| K180808 | Omni Foot Plating System | May 22, 2018 | Substantially Equivalent | Extremity Medical, LLC |
| K180239 | Additive Orthopaedics Patient Specific 3D Printed Bone Segments | May 16, 2018 | Substantially Equivalent | Additive Orthopaedics, LLC |
| K171690 | Trident Extremity Fixation System | May 08, 2018 | Substantially Equivalent | Trident Orthopedics |
| K173767 | A. L. P. S. Clavicle Plating System | Apr 06, 2018 | Substantially Equivalent | Biomet Inc. |
| K171624 | IXOS Radius Plate System | Mar 29, 2018 | Substantially Equivalent | Stuckenbrock Medizintechnik GmbH |
| K173930 | PYTHON Plate Trial Instruments | Mar 19, 2018 | Substantially Equivalent | Treace Medical Concepts, Inc. |
| K172148 | Anchorage Bone Plating System | Mar 19, 2018 | Substantially Equivalent | Stryker GmbH |
| K171808 | TDM Plate and Screw System | Mar 15, 2018 | Substantially Equivalent | TDM Co. Ltd. |
| K171320 | ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws | Mar 08, 2018 | Substantially Equivalent | Meril Healthcare Pvt. Ltd. |
| K173746 | Activmotion Range | Feb 27, 2018 | Substantially Equivalent | Newclip Technics |
| K172294 | Osteotomy Truss System (OTS) | Feb 22, 2018 | Substantially Equivalent | 4Web, Inc. |
| K173641 | Activ Ankle | Jan 16, 2018 | Substantially Equivalent | Newclip Technics |
| K173293 | EVOS Small Fragment Upper Extremity Plates | Jan 08, 2018 | Substantially Equivalent | Smith & Nephew, Inc. |
| K171372 | Alians Elbow Locking Plating System | Jan 04, 2018 | Substantially Equivalent | Newclip Technics |
| K172973 | Life Spine Foot and Ankle Plating System | Dec 21, 2017 | Substantially Equivalent | Life Spine Inc. |
| K172886 | Breakaway Screw System | Dec 20, 2017 | Substantially Equivalent | Paragon 28 |
| K172350 | AxSOS 3 Ti | Dec 15, 2017 | Substantially Equivalent | Stryker GmbH |
| K172786 | MDS Plating System | Dec 08, 2017 | Substantially Equivalent | Miami Device Solutions, LLC |
| K172425 | OrthoPediatrics Wrist Fusion Plate | Dec 06, 2017 | Substantially Equivalent | OrthoPediatrics, Inc. |
| K172008 | ARIX Humerus System | Dec 01, 2017 | Substantially Equivalent | Jeil Medical Corporation |
| K173121 | Ankle Fusion Plating System | Nov 28, 2017 | Substantially Equivalent | In2Bones SAS |
| K172300 | CoLink View Plating System | Nov 27, 2017 | Substantially Equivalent | In2Bones USA, LLC |
| K172178 | Minimally Invasive Bunion Plating System | Nov 16, 2017 | Substantially Equivalent | Trilliant Surgical, LTD |
| K173166 | ANTHEM Fracture System | Nov 13, 2017 | Substantially Equivalent | Globus Medical Inc. |
| K172441 | EPIC Extremity Fracture Plate System | Nov 06, 2017 | Substantially Equivalent | EPIC Extremity, LLC |
| K172260 | Omni Foot Plating System | Nov 06, 2017 | Substantially Equivalent | Extremity Medical, LLC. |
| K171293 | G3 Active Plate® Miniature System | Oct 23, 2017 | Substantially Equivalent | Genesis Fracture Care, Inc. |
| K171852 | DARCO Locking Bone Plate System | Sep 21, 2017 | Substantially Equivalent | Wright Medical Technology, Inc. |
| K170705 | ARIX Wrist System | Sep 21, 2017 | Substantially Equivalent | Jeil Medical Corporation |
| K172170 | APTUS(R) Wrist 2.5 System | Sep 08, 2017 | Substantially Equivalent | Medartis AG |
| K171510 | Footmotion Plating System | Sep 08, 2017 | Substantially Equivalent | Newclip Technics |
| K170547 | Arthrex Mesh Plate System | Sep 01, 2017 | Substantially Equivalent | Arthrex, Inc. |
| K171173 | OrthoPediatrics Titanium PediPlates® System | Aug 24, 2017 | Substantially Equivalent | OrthoPediatrics, Corp. |
| K172262 | EVOS Small Fragment Plating System | Aug 23, 2017 | Substantially Equivalent | Smith & Nephew, Inc. |
| K170979 | ARIX Ankle Fibula Hook Plate System | Aug 17, 2017 | Substantially Equivalent | Jeil Medical Corporation |
| K170780 | ARIX Foot System (2.3/2.8) | Aug 14, 2017 | Substantially Equivalent | Jeil Medical Corporation |
| K162507 | Arzzt 3.5 / 4.5 Small & Large Fragments System | Aug 03, 2017 | Substantially Equivalent | TRUEMED GROUP, LLC |
| K170313 | ARIX Ankle Distal Tibia System | Jul 27, 2017 | Substantially Equivalent | Jeil Medical Corporation |
| K171285 | ARIX Diaphysis System | Jul 24, 2017 | Substantially Equivalent | Jeil Medical Corporation |
| K170518 | In2Bones Fracture and Correction System | Jul 14, 2017 | Substantially Equivalent | In2BonesUSA, LLC |
| K160553 | DePuy Synthes 4.0 mm and 5.0 mm Locking Screws MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System MR Conditional, DePuy Synthes Modular Foot System MR Conditional, DePuy Synthes T-Plates MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) MR Conditional, DePuy Synthes Stainless S | Jun 30, 2017 | Substantially Equivalent | SYNTHES (USA) PRODUCTS LLC/DEPUY ORTHOPAEDICS INC |
| K171590 | Distal Elbow Plating System | Jun 27, 2017 | Substantially Equivalent | Skeletal Dynamics, LLC |
| K170727 | VariAx 2 Compression Plating System | Jun 22, 2017 | Substantially Equivalent | Stryker GmbH |
| K163593 | Additive Orthopaedics Bunion System | Jun 20, 2017 | Substantially Equivalent | Additive Orthopaedics, LLC. |
| K170843 | Alians Fragment Specific | Jun 16, 2017 | Substantially Equivalent | Newclip Technics |
| K162674 | BioPro Foot Plating Systems | Jun 16, 2017 | Substantially Equivalent | BIOPRO, INC. |
| K170457 | EVOS Small Fragment Lower Extremity Plates | Jun 14, 2017 | Substantially Equivalent | Smith & Nephew, Inc. |
| K170401 | Piccolo Composite® Plate System | May 12, 2017 | Substantially Equivalent | CarboFix Orthopedics Ltd. |
| K170771 | VariAx 2 Foot System | May 08, 2017 | Substantially Equivalent | Stryker GmbH |
| K163293 | Colink Plating System | May 05, 2017 | Substantially Equivalent | IN2BONESUSA, LLC |
| K162380 | Locking Plate System | May 02, 2017 | Substantially Equivalent | BEIJING KEYI MEDICAL DEVICE TECHNOLOGY CO., LTD. |
| K170887 | EVOS Small Fragment Plating System | Apr 24, 2017 | Substantially Equivalent | Smith & Nephew, Inc. |
| K163650 | ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension | Apr 24, 2017 | Substantially Equivalent | Wright Medical Technology, Inc. |
| K162154 | Pantheon Medical Balanced Plating System | Apr 24, 2017 | Substantially Equivalent | PANTHEON MEDICAL |
| K163383 | GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System | Apr 19, 2017 | Substantially Equivalent | GREENS SURGICALS PVT. LTD. |
| K170214 | Additive Orthopaedics Locking Lattice Plate | Apr 13, 2017 | Substantially Equivalent | Additive Orthopaedics, LLC |
| K163361 | ANTHEM Fracture System | Apr 07, 2017 | Substantially Equivalent | Globus Medical Inc. |
| K170310 | Alians Clavicle range | Mar 30, 2017 | Substantially Equivalent | Newclip Technics |
| K163425 | NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System | Mar 24, 2017 | Substantially Equivalent | NARANG MEDICAL USA CORPORATION |
| K162898 | Olecranon Plating System | Mar 17, 2017 | Substantially Equivalent | MIAMI DEVICE SOLUTIONS, LLC |
| K163003 | Y3 Proximal Femoral Plate System | Mar 16, 2017 | Substantially Equivalent | PEGA MEDICAL INC. |
| K163039 | ORTHOLOC® 3Di Small Bones Plating | Mar 13, 2017 | Substantially Equivalent | Wright Medical Technology, Inc. |
| K170124 | Level One Hand Plating System | Mar 09, 2017 | Substantially Equivalent | KLS MARTIN LP |
| K162841 | VariAx Distal Radius Plating System, VariAx 2 System | Feb 21, 2017 | Substantially Equivalent | Stryker GmbH |
| K162391 | AlignMATE Lapidus Arthrodesis System | Feb 21, 2017 | Substantially Equivalent | ARTHROSURFACE, INC. |
| K163046 | DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long | Feb 09, 2017 | Substantially Equivalent | DEPUY SYNTHES |
| K161861 | APTUS® Coronoid 2.0 | Feb 09, 2017 | Substantially Equivalent | Medartis AG |
| K162439 | AxSOS 3 Ti; Stryker Plating System | Feb 03, 2017 | Substantially Equivalent | STRYKER GMBH |
| K163044 | ORTHOLOC® 3Di Ankle Fracture Plating System | Jan 26, 2017 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K161303 | dynaMX Compression Plate | Jan 26, 2017 | Substantially Equivalent | MX ORTHOPEDICS, CORP. |
| K162179 | osteo-WEDGE II ® Open Wedge Bone Locking Plate System | Jan 10, 2017 | Substantially Equivalent | GRAHAM MEDICAL TECHNOLOGIES, L.L.C. DBA GRAMEDICA |
| K163086 | VLP MINI-MOD 2.0mm Column Plates | Dec 21, 2016 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K162974 | Biomet Microfixation RibFix Blu Thoracic Fixation System | Dec 09, 2016 | Substantially Equivalent | Biomet Microfixation |
| K162829 | Medline UNITE® Ankle Fracture Plating System | Dec 09, 2016 | Substantially Equivalent | MEDLINE, INDUSTRIES, INC. |
| K163007 | Biomet Microfixation SternaLock 360 Sternal Closure System | Nov 23, 2016 | Substantially Equivalent | BIOMET MICROFIXATION |
| K161696 | aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 | Nov 23, 2016 | Substantially Equivalent | AAP IMPLANTATE AG |
| K161747 | LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5 | Nov 22, 2016 | Substantially Equivalent | aap Implantate AG |
| K162078 | EVOS Small Fragment Plating System | Nov 18, 2016 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K161665 | VLP Wrist Fracture System | Nov 15, 2016 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K161913 | AOS Small Fragment Plating System | Nov 04, 2016 | Substantially Equivalent | ADVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS) |
| K161703 | LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer | Nov 04, 2016 | Substantially Equivalent | AAP IMPLANTATE AG |
| K161590 | MatrixRIB Fixation System | Nov 03, 2016 | Substantially Equivalent | SYNTHES (USA) PRODUCTS LLC |
| K161448 | Footmotion Plating System | Oct 31, 2016 | Substantially Equivalent | NEWCLIP TECHNICS |
| K162635 | Distal Radius Plating System | Oct 21, 2016 | Substantially Equivalent | Miami Device Solutions, LLC |
| K162424 | Ulna Plating System | Oct 12, 2016 | Substantially Equivalent | BIOMET INC |
| K162307 | OrthoPediatrics Locking Proximal Femur System Cortical Screws | Sep 27, 2016 | Substantially Equivalent | ORTHOPEDIATRICS, CORP. |
| K161746 | ARIX Hand System | Sep 21, 2016 | Substantially Equivalent | Jeil Medical Corporation |
| K153207 | Additive Orthopaedics Bone Wedge System | Sep 07, 2016 | Substantially Equivalent | Additive Orthopaedics, LLC |
| K152289 | Alians Elbow Locking Plating System | Aug 17, 2016 | Substantially Equivalent | NEWCLIP TECHNICS |
| K161292 | Distal Radius Plating System | Aug 15, 2016 | Substantially Equivalent | MIAMI DEVICE SOLUTIONS, LLC |
| K161037 | Tarsa-Link Stand-Alone Wedge Fixation System | Aug 15, 2016 | Substantially Equivalent | LIFE SPINE INC. |
| K153573 | Converge | Aug 11, 2016 | Substantially Equivalent | BIOMEDICAL ENTERPRISES, INC |
| K161896 | Biomet Microfixation Sternal Closure System | Aug 02, 2016 | Substantially Equivalent | BIOMET MICROFIXATION |
| K161864 | ARIX Foot System | Aug 02, 2016 | Substantially Equivalent | JEIL MEDICAL CORPORATION |
| K161048 | Conventus Orthopaedics Ulna Fixation System | Jul 26, 2016 | Substantially Equivalent | CONVENTUS ORTHOPAEDICS, INC. |
| K153374 | CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System | Jun 17, 2016 | Substantially Equivalent | ORTHOCARE |
| K160995 | NEOVIEW Plating System | Jun 10, 2016 | Substantially Equivalent | In2Bones SAS |
| K153379 | AxSOS 3Ti | May 26, 2016 | Substantially Equivalent | Stryker GmbH |
| K161041 | OsteoMed ExtremiLOCK Wrist Plating System | May 19, 2016 | Substantially Equivalent | OSTEOMED |
| K153716 | GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. | May 17, 2016 | Substantially Equivalent | GPC MEDICAL LTD |
| K152062 | BIOFOAM Bone Wedge | May 17, 2016 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K160633 | G3(TM) Active Plate(R) Small Fragment System | Apr 22, 2016 | Substantially Equivalent | GENESIS FRACTURE CARE, INC. |
| K160300 | MotoBand(TM) CP Implant System | Apr 22, 2016 | Substantially Equivalent | CrossRoads Extremity Systems, LLC |
| K160177 | Gridlock Ankle Plating System | Apr 22, 2016 | Substantially Equivalent | Trilliant Surgical, LTD |
| K153482 | KLS Martin Thoracic Plating System | Apr 06, 2016 | Substantially Equivalent | KLS-MARTIN L.P. |
| K160191 | Align Anterior Ankle Fusion Plate | Mar 25, 2016 | Substantially Equivalent | Extremity Medical, LLC |
| K152253 | Biomet Microfixation RibFix Blu Thoracic Fixation System | Mar 24, 2016 | Substantially Equivalent | BIOMET MICROFIXATION |
| K160002 | Piccolo Composite(R) Distal Volar Radius Plate System | Mar 09, 2016 | Substantially Equivalent | CARBOFIX ORTHOPEDICS LTD. |
| K151508 | IRENE Locking Compression Plate System | Feb 25, 2016 | Substantially Equivalent | TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD |
| K153340 | Epic Extremity Plate System | Feb 09, 2016 | Substantially Equivalent | Epic Extremity, LLC |
| K151735 | TriMed Humeral Supracondylar Fixation System | Jan 29, 2016 | Substantially Equivalent | TriMed, Inc. |
| K151716 | Cable-Ready Cable Grip System: Cable-Ready Bone Plate System | Jan 28, 2016 | Substantially Equivalent | ZIMMER, INC. |
| K153034 | aap LOQTEQ VA Radius Set 2.5 | Jan 21, 2016 | Substantially Equivalent | AAP IMPLANTATE AG |
| K151468 | ARIX Wrist System | Jan 14, 2016 | Substantially Equivalent | Jeil Medical Corporation |
| K153531 | Treace Medical Concepts (TMC) Plating System | Jan 07, 2016 | Substantially Equivalent | TREACE MEDICAL CONCEPTS, INC. |
| K152548 | AXI+LINE Proximal Bunion Correction System | Dec 21, 2015 | Substantially Equivalent | NEXTREMITY SOLUTIONS, Inc. |
| K152145 | OsteoMed ExtremiLOCK Wrist Plating System | Dec 21, 2015 | Substantially Equivalent | OSTEOMED |
| K152974 | ORTHOLOC® 3Di Foot Plating Reconstruction System | Dec 11, 2015 | Substantially Equivalent | Wright Medical Technology, Inc. |
| K152306 | MotoBand¿ CP Implant System | Dec 11, 2015 | Substantially Equivalent | CROSSROADS EXTREMITY SYSTEMS, LLC |
| K152732 | AOS Small Fragment Plating System | Dec 10, 2015 | Substantially Equivalent | AVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS) |
| K152000 | SMV Scientific Bone Plate and Screw System | Nov 25, 2015 | Substantially Equivalent | SMV Scientific |
| K150561 | NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System | Nov 25, 2015 | Substantially Equivalent | Narang Medical Limited |
| K152242 | G3¿ Active Plate® Large Fragment System | Nov 24, 2015 | Substantially Equivalent | GENESIS FRACTURE CARE, INC. |
| K152976 | VLP Mini-Mod Talus Plates | Nov 12, 2015 | Substantially Equivalent | Smith & Nephew, Inc. |
| K152256 | RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and Screws | Nov 05, 2015 | Substantially Equivalent | NORMED MEDIZIN-TECHNIK GMBH |
| K151019 | SternaLock® 360 Sternal Closure System | Nov 03, 2015 | Substantially Equivalent | BIOMET MICROFIXATION |
| K152312 | RECON system-V-TEK-IVP Plates and Screws | Oct 30, 2015 | Substantially Equivalent | NORMED MEDIZIN-TECHNIK GMBH |
| K151886 | Acumed Ankle and Small Fragment Base Set Update | Oct 30, 2015 | Substantially Equivalent | Acumed, LLC |
| K151769 | Anchorage 2 CP System | Oct 27, 2015 | Substantially Equivalent | STRYKER GMBH |
| K152142 | RECON system - MPJ-Plates | Sep 16, 2015 | Substantially Equivalent | NORMED MEDIZIN-TECHNIK GMBH |
| K151442 | TOTAL COMPRESSION PLATING (TCP) SYSTEM | Sep 04, 2015 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K151732 | Arthrex Fracture Plates | Aug 28, 2015 | Substantially Equivalent | ARTHREX, INC. |
| K143721 | PRCT2 | Aug 27, 2015 | Substantially Equivalent | FX SOLUTIONS |
| K151379 | Conventus PRS System | Aug 13, 2015 | Substantially Equivalent | Conventus Orthopaedics, Inc |
| K151277 | Airlock® osteosynthesis plate system | Aug 13, 2015 | Substantially Equivalent | NOVASTEP |
| K151407 | RECON system | Aug 12, 2015 | Substantially Equivalent | NORMED MEDIZIN-TECHNIK GMBH |
| K151057 | WASTON Metallic Bone Plate and Screw Systems | Aug 10, 2015 | Substantially Equivalent | CHANGZHOU WASTON MEDICAL APPLIANCE CO. LTD |
| K151879 | VariAx 2 One-Third Tubular Plating System | Aug 06, 2015 | Substantially Equivalent | STRYKER GMBH |
| K151235 | Medline Foot Plates and Screws | Aug 06, 2015 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K142943 | Metallic Locking Bone Plate and Screw | Aug 03, 2015 | Substantially Equivalent | Canwell Medical Co., Ltd |
| K141680 | AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking Screws | Jun 30, 2015 | Substantially Equivalent | AUXEIN MEDICAL |
| K151178 | VariAx 2 Wrist Fusion System | Jun 24, 2015 | Substantially Equivalent | Stryker Trauma AG |
| K142906 | APTUS Wrist 2.5 System | Jun 09, 2015 | Substantially Equivalent | MEDARTIS AG |
| K143002 | Metallic Locking Bone Plate and Screw System | Jun 05, 2015 | Substantially Equivalent | Changzhou Dingjian Medical Appliance Co., Ltd |
| K143496 | Piccolo Composite Plate System | May 29, 2015 | Substantially Equivalent | CarboFix Orthopedics Ltd. |
| K142724 | BIOFOAM Bone Wedge | May 20, 2015 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K150675 | Dorsal Spanning Plate | May 12, 2015 | Substantially Equivalent | SKELETAL DYNAMICS, LLC |
| K150649 | G3 Active Plate Large Fragment System | Apr 30, 2015 | Substantially Equivalent | GENESIS FRACTURE CARE, INC. |
| K150520 | DARCO Locking Bone Plate System | Apr 29, 2015 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K150456 | Arthrex Plates, Screws, and Staples | Apr 29, 2015 | Substantially Equivalent | Arthrex, Inc. |
| K142581 | APTUS Foot System | Apr 09, 2015 | Substantially Equivalent | MEDARTIS AG |
| K143523 | Airlock osteosynthesis plate system | Apr 06, 2015 | Substantially Equivalent | NOVASTEP |
| K143385 | Acumed Ankle Plating System | Apr 06, 2015 | Substantially Equivalent | Acumed, llc |
| K143749 | Arthrex Distal Radius System | Apr 03, 2015 | Substantially Equivalent | Arthrex, Inc. |
| K143697 | Biomet Proximal Humerus Plating System | Mar 30, 2015 | Substantially Equivalent | Biomet Manufacturing |
| K143365 | Eminent Foot Plate System | Mar 30, 2015 | Substantially Equivalent | Eminent Spine |
| K141527 | DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM | Mar 30, 2015 | Substantially Equivalent | SYNTHES USA |
| K150368 | Tarsa-Link Wedge Fixation System | Mar 24, 2015 | Substantially Equivalent | Life Spine |
| K150099 | Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws) | Mar 23, 2015 | Substantially Equivalent | SYNTHES (USA) PRODUCTS, LLC |
| K141493 | PROXIMAL HUMERUS PLATING SYSTEM | Mar 20, 2015 | Substantially Equivalent | Miami Device Solutions |
| K143717 | Treace Medical Concepts(TMC) Plating System | Mar 19, 2015 | Substantially Equivalent | Treace Medical Concepts, INc. |
| K143331 | Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS | Mar 04, 2015 | Substantially Equivalent | ZIMMER, INC. |
| K141825 | IDEAL Locking Plate System | Mar 03, 2015 | Substantially Equivalent | JIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LT |
| K150009 | Baide | Feb 25, 2015 | Substantially Equivalent | Jiangsu Baide Medical Intrument Co.,Ltd. |
| K142823 | Biomet Microfixation Thoracic Fixation System | Feb 25, 2015 | Substantially Equivalent | BIOMET MICROFIXATION |
| K150121 | Zimmer Periarticular Plating System | Feb 23, 2015 | Substantially Equivalent | ZIMMER,INC. |
| K141548 | HIGH TIBIAL OSTEOTOMY SYSTEM | Jan 30, 2015 | Substantially Equivalent | NEWCLIP TECHNICS |
| K143061 | Activ Ankle Locking Plating System | Jan 26, 2015 | Substantially Equivalent | NEWCLIP TECHNICS |
| K143394 | Acumed Small Fragment Base Set | Jan 23, 2015 | Substantially Equivalent | ACUMED LLC |
| K143139 | Arthrex Fracture System | Jan 16, 2015 | Substantially Equivalent | ARTHREX, INC. |
| K143023 | Nitinol Compression Plating System | Jan 16, 2015 | Substantially Equivalent | BioMedical Enterprises, Inc. |
| K142502 | ALIANS ULNA LOCKING PLATING SYSTEM | Dec 23, 2014 | Substantially Equivalent | NEWCLIP TECHNICS |
| K143138 | AxSOS 3 Ti Locking Plate System | Dec 22, 2014 | Substantially Equivalent | Stryker Trauma AG |
| K143050 | VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws | Dec 18, 2014 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K142419 | Mini and Micro Fragments Reconstruction System-NEOFIX | Dec 16, 2014 | Substantially Equivalent | NEOORTHO PRODUCTOS ORTHOPEDICOS S/A |
| K143025 | TOTAL COMPRESSION PLATING SYSTEM | Dec 05, 2014 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K143066 | Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws and Washers | Nov 28, 2014 | Substantially Equivalent | ZIMMER, INC. |
| K142938 | G3 Active Plate Large Fragment System | Nov 26, 2014 | Substantially Equivalent | GENESIS FRACTURE CARE, INC. |
| K142836 | Zimmer Plates and Screws (ZPS), Forte Screws | Nov 12, 2014 | Substantially Equivalent | ZIMMER, INC. |
| K142484 | Sternal Closure System | Oct 31, 2014 | Substantially Equivalent | JACE Medical LLC |
| K142579 | Zimmer Periarticular Plating System | Oct 22, 2014 | Substantially Equivalent | ZIMMER, INC. |
| K142418 | I.T.S. Hand Locking Plates System - HLS | Sep 26, 2014 | Substantially Equivalent | I.T.S. GmbH |
| K141905 | PRO-LINK WEDGE SYSTEM | Sep 26, 2014 | Substantially Equivalent | LIFE SPINE |
| K142306 | Flower Upper Extremity Plating Set | Sep 15, 2014 | Substantially Equivalent | Flower Orthopedics Corporation |
| K141796 | DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM | Aug 29, 2014 | Substantially Equivalent | SYNTHES (USA) PRODUCTS LLC |
| K142135 | REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION | Aug 28, 2014 | Substantially Equivalent | ICON ORTHOPEDIC CONCEPTS, LLC DBA EDGE ORTHOPAEDIC |
| K140892 | DISTAL ELBOW PLATING SYSTEM | Aug 28, 2014 | Substantially Equivalent | SKELETAL DYNAMICS, LLC |
| K142121 | VALOR HINDFOOT FUSION NAIL SYSTEM | Aug 21, 2014 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K141735 | ARTHREX ANKLE FUSION PLATING SYSTEM | Aug 15, 2014 | Substantially Equivalent | ARTHREX, INC. |
| K140508 | ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWS | Aug 14, 2014 | Substantially Equivalent | ZIMMER, INC. |
| K141734 | ZIMMER PERIARTICULAR LOCKING SYSTEM | Aug 13, 2014 | Substantially Equivalent | ZIMMER, INC. |
| K141517 | ZIMMER PLATES AND SCREWS (ZPS)-NON-STERILE PLATES | Aug 13, 2014 | Substantially Equivalent | ZIMMER, INC. |
| K141992 | VARIAX 2 SYSTEM | Aug 07, 2014 | Substantially Equivalent | Stryker Trauma AG |
| K141823 | AAP LOQTEC CLAVICLE PLATES 2.7/3.5 | Aug 07, 2014 | Substantially Equivalent | AAP IMPLANTATE AG |
| K141241 | MATRIXRIB ENDO THORACOSCOPIC RIB PLATING SYSTEM | Aug 07, 2014 | Substantially Equivalent | SYNTHES (USA) PRODUCTS LLC |
| K140431 | PEDILOC FRAGMENT SYSTEM | Jul 29, 2014 | Substantially Equivalent | ORTHOPEDIATRICS, CORP. |
| K133840 | Kangli Locking Plate System | Jul 29, 2014 | Substantially Equivalent | SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD |
| K141489 | LINOS MOH HAND PLATING SYSTEM | Jul 24, 2014 | Substantially Equivalent | KLS MARTIN L.P. |
| K141784 | ORTHO SOLUTIONS ULTOS PLATING SYSTEM | Jul 23, 2014 | Substantially Equivalent | ORTHO SOLUTIONS LIMITED |
| K141677 | VARIAX ELBOW PLATING SYSTEM | Jul 22, 2014 | Substantially Equivalent | Stryker Trauma AG |
| K140876 | VIEW PLATING SYSTEM,REDUCE FRACTURE PLATING SYSTEM,BONE SCREW | Jul 22, 2014 | Substantially Equivalent | ICON ORTHOPEDIC CONCEPTS, LLC DBA EDGE ORTHOPAEDIC |
| K141430 | VARIAX DISTAL RADIUS PLATING SYSTEM | Jul 18, 2014 | Substantially Equivalent | Stryker Leibinger GmbH & Co. KG |
| K141301 | MAXLOCK EXTREME ELBOW FRACTURE SYSTEM | Jul 11, 2014 | Substantially Equivalent | ORTHOHELIX SURGICAL DESIGNS, INC. |
| K141417 | CHARLOTTE (TM) MTP BONE FUSION PLATE SYSTEM HEX SCREW | Jul 09, 2014 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K140531 | BIOFOAM BONE WEDGE | Jul 09, 2014 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K141478 | ARTHREX FRACTURE PLATES AND SCREWS | Jul 08, 2014 | Substantially Equivalent | ARTHREX, INC. |
| K141045 | MBD PLATE SYSTEM | Jun 30, 2014 | Substantially Equivalent | MBD MEDICAL, LLC |
| K141232 | APTUS ULNA SHORTENING 2.5 | Jun 23, 2014 | Substantially Equivalent | MEDARTIS AG |
| K141204 | VARIAX 2 ONE THIRD TUBULAR PLATING SYSTEM | Jun 20, 2014 | Substantially Equivalent | Stryker Trauma AG |
| K141121 | AXSOS 3 TI LOCKING PLATE SYSTEM | Jun 20, 2014 | Substantially Equivalent | Stryker Trauma AG |
| K141383 | ACUMED HAND FRACTURE SYSTEM | Jun 13, 2014 | Substantially Equivalent | ACUMED, LLC |
| K140357 | OIC VARIABLE ANGLE SMALL FRAGMENT LOCKING PLATE SYSTEM | Jun 09, 2014 | Substantially Equivalent | ORTHOPAEDIC IMPLANT COMPANY |
| K140226 | OTIS-C-PLUS, NEOTIS PLATE, SCREW 06.5 | Jun 03, 2014 | Substantially Equivalent | SCIENCE FOR BIOMATERIALS |
| K140565 | VARIAX 2 COMPRESSION PLATING SYSTEM | May 29, 2014 | Substantially Equivalent | Stryker Trauma AG |
| K140792 | SALVATION 3DI PLATING SYSTEM | May 22, 2014 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K140724 | MSP METATARSAL SHORTENING SYSTEM | May 14, 2014 | Substantially Equivalent | NEXTREMITY SOLUTIONS, INC. |
| K140622 | DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE | May 13, 2014 | Substantially Equivalent | BIOMET, INC. |
| K140607 | AAP LOQTEC(R) OLECRANON PLATE | May 08, 2014 | Substantially Equivalent | AAP IMPLANTATE AG |
| K140814 | EVOS MINI-FRAGMENT PLATING SYSTEM | May 07, 2014 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K133616 | MATRIXRIB FIXATION SYSTEM | May 02, 2014 | Substantially Equivalent | SYNTHES (USA) PRODUCTS LLC |
| K140216 | ORTHOPEDIC FIXATION SYSTEMS | May 01, 2014 | Substantially Equivalent | IMPACT MEDICAL, LLC |
| K140617 | PINIT SMALL BONE FUSION SYSTEM | Apr 25, 2014 | Substantially Equivalent | ARTHROSURFACE, INC. |
| K140769 | VARIAX 2 SYSTEM | Apr 17, 2014 | Substantially Equivalent | Stryker Trauma AG |
| K140397 | PARALOCK PLATING SYSTEM / TUFFNEK SCREW | Apr 17, 2014 | Substantially Equivalent | PARAGON 28 |
| K140372 | FRAGMENT PLATE SYSTEM | Apr 07, 2014 | Substantially Equivalent | SKELETAL DYNAMICS, LLC |
| K140069 | LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0 | Apr 07, 2014 | Substantially Equivalent | MERETE MEDICAL GMBH |
| K140376 | VARIAX 2 SYSTEM | Apr 03, 2014 | Substantially Equivalent | Stryker Trauma AG |
| K140259 | VARIAX CLAVICLE HOOK PLATE | Apr 01, 2014 | Substantially Equivalent | Stryker Trauma AG |
| K133939 | MODIFIED DISTAL RADIUS PLATING SYSTEM | Apr 01, 2014 | Substantially Equivalent | BIOMET |
| K133930 | FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET | Mar 27, 2014 | Substantially Equivalent | FLOWER ORTHOPEDICS CORPORATION |
| K133974 | VARIAX DISTAL RADIUS PLATING SYSTEM | Mar 24, 2014 | Substantially Equivalent | STRYKER LEIBINGER GMBH |
| K140107 | EMERGE MEDICAL DISTAL RADIUS SET | Mar 13, 2014 | Substantially Equivalent | EMERGE MEDICAL |
| K140119 | EMERGE MEDICAL PERIARTICULAR AND LOCKING LARGE FRAGMENT SYSTEM | Mar 12, 2014 | Substantially Equivalent | EMERGE MEDICAL |
| K140098 | EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM | Mar 12, 2014 | Substantially Equivalent | EMERGE MEDICAL |
| K133525 | LOCKING COMPRESSION BONE PLATES AND SCREW SYSTEM | Mar 04, 2014 | Substantially Equivalent | CHANGZHOU DEAN MEDICAL INSTRUMENT CO, LTD |
| K133668 | AFT GREATER TUBEROSITY FRACTURE PLATE, LEFT, AFT GREATER TUBEROSITY FRACTURE PLATE, RIGHT, AFT GREATER TUBEROSITY CANNUL | Mar 03, 2014 | Substantially Equivalent | SHOULDER OPTIONS, INC. |
| K133715 | CHARLOTTE CLAW PLATE SYSTEM | Feb 28, 2014 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K133536 | EMERGE MEDICAL BONE PLATE SYSTEM | Feb 26, 2014 | Substantially Equivalent | EMERGE MEDICAL |
| K133691 | EXTRIMILOCK ANKLE PLATING SYSTEM | Feb 24, 2014 | Substantially Equivalent | OSTEOMED LP |
| K131552 | CONVENTUS DRS | Feb 12, 2014 | Substantially Equivalent | CONVENTUS ORTHOPAEDICS |
| K132886 | SMITH & NEPHEW VARIABLE-ANGLE LOCKING MINI-FRAGMENT PLATING SYSTEM | Feb 04, 2014 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K133541 | EMERGE MEDICAL SMALL AND LARGE NON-LOCKING FRAGMENT PLATE SYSTEM | Jan 28, 2014 | Substantially Equivalent | EMERGE MEDICAL |
| K133675 | AAP LOQTEQ DISTAL ANTEROLATERAL TIBIA PLATE 3.5 | Jan 23, 2014 | Substantially Equivalent | AAP IMPLANTATE AG |
| K130614 | BONE FRAGMENT AND FIXATION PLATES, SCREWS AND WASHERS | Jan 17, 2014 | Substantially Equivalent | LAURA CATTABRIGA |
| K133452 | EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM | Jan 08, 2014 | Substantially Equivalent | EMERGE MEDICAL |
| K132296 | D-RAD SMART PACK | Jan 07, 2014 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K132769 | ACUMED HAND PLATING SYSTEM | Jan 06, 2014 | Substantially Equivalent | ACUMED LLC |
| K132787 | LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE | Dec 24, 2013 | Substantially Equivalent | AAP IMPLANTATE AG |
| K132876 | ARIX HAND LOCKING SYSTEM | Dec 18, 2013 | Substantially Equivalent | JEIL MEDICAL CORPORATION |
| K133246 | ZIMMER DISTAL RADIUS PLATING SYSTEM | Dec 17, 2013 | Substantially Equivalent | ZIMMER, INC. |
| K132594 | CROSSCHECK PLATING SYSTEM | Dec 13, 2013 | Substantially Equivalent | SOLANA SURGICAL, LLC |
| K133437 | 1ST MTP PLATE | Dec 02, 2013 | Substantially Equivalent | OSTEOMED |
| K132898 | A.L.P.S. CALCANEAL PLATING SYSTEM | Nov 19, 2013 | Substantially Equivalent | BIOMET MANUFACTURING CORP. |
| K133102 | FLOWER ANKLE PLATING SET | Nov 18, 2013 | Substantially Equivalent | FLOWER ORTHOPEDICS CORPORATION |
| K131782 | LOQTEQ HIGH TIBIA OSTEOTOMY PLATE 4.5 | Nov 18, 2013 | Substantially Equivalent | AAP IMPLANTATE AG |
| K131834 | WOLF LONG BONE PLATE SYSTEM | Nov 04, 2013 | Substantially Equivalent | TOBY ORTHOPAEDICS |
| K131566 | ARIX HAND SYSTEM | Nov 04, 2013 | Substantially Equivalent | JEIL MEDICAL CORPORATION |
| K131867 | 2.5MM INLINE FUSION PLATE | Oct 29, 2013 | Substantially Equivalent | BIOMET, INC. |
| K132502 | VARIAX 2 SYSTEM | Oct 23, 2013 | Substantially Equivalent | Stryker Trauma AG |
| K131186 | SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM | Oct 08, 2013 | Substantially Equivalent | SYNTHES (USA) PRODUCTS LLC |
| K132642 | LOCKING PLATE SYSTEM | Oct 03, 2013 | Substantially Equivalent | BEIJING LIBEIER BIO-ENGINEERING INSTITUTE CO., LTD |
| K132554 | AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5 | Oct 03, 2013 | Substantially Equivalent | AAP IMPLANTATE AG |
| K130510 | ARTHREX COMPRESSION PLATES | Sep 25, 2013 | Substantially Equivalent | ARTHREX, INC. |
| K132591 | MAXLOCK EXTREME SYSTEM | Sep 17, 2013 | Substantially Equivalent | ORTHOHELIX SURGICAL DESIGNS, INC. |
| K131764 | ACUMED WRIST SPANNING PLATE | Sep 05, 2013 | Substantially Equivalent | ACUMED LLC |
| K131311 | ARIX FOOT SYSTEM | Sep 05, 2013 | Substantially Equivalent | JEIL MEDICAL CORPORATION |
| K131657 | FLOWER SMALL AND MEDIUM IMPLANT SET | Aug 22, 2013 | Substantially Equivalent | FLOWER ORTHOPEDICS CORPORATION |
| K132226 | METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT | Aug 09, 2013 | Substantially Equivalent | MERETE MEDICAL GMBH |
| K131759 | METALLIC LOCKING COMPRESSION BONE PLATES AND SCREWS SYSTEM | Aug 08, 2013 | Substantially Equivalent | TIANJIN WALKMAN BIOMATERIAL CO., LTD. |
| K131722 | I.T.S. EXTREMITY FIXATION SYSTEMS | Aug 07, 2013 | Substantially Equivalent | I.T.S. GMBH |
| K131360 | INTEGRA TITANIUM BONE WEDGE | Aug 07, 2013 | Substantially Equivalent | ASCENSION ORTHOPEDIC |
| K123347 | NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0 | Aug 02, 2013 | Substantially Equivalent | NORMED MEDIZIN-TECHNIK GMBH |
| K130731 | STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW | Jul 19, 2013 | Substantially Equivalent | STABILIZ ORTHOPAEDICS, LLC |
| K131670 | LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT) | Jul 03, 2013 | Substantially Equivalent | BIOMET, INC. |
| K131480 | EMERGE MEDICAL LOCKING ONE-THIRD TUBULAR PLATE SYSTEM | Jul 03, 2013 | Substantially Equivalent | EMERGE MEDICAL |
| K131474 | ARTHREX DISTAL RADIUS PLATE SYSTEM | Jul 03, 2013 | Substantially Equivalent | ARTHREX, INC. |
| K130008 | DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0 CANCELLOUS LOCKING SCREW, 3.0 CORTICAL LOCKING | Jun 25, 2013 | Substantially Equivalent | I.T.S. GMBH |
| K130774 | UNIVERSAL DISTAL RADIUS SYSTEM | Jun 19, 2013 | Substantially Equivalent | NEWCLIP TECHNICS |
| K131445 | OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM | Jun 18, 2013 | Substantially Equivalent | OSTEOMED LP |
| K131380 | ACUMED TOTALW RIST FUSION PLATING SYSTEM | Jun 10, 2013 | Substantially Equivalent | ACUMED LLC |
| K130185 | 4WEB OSTEOTOMY BONE WEDGE | Jun 07, 2013 | Substantially Equivalent | 4-WEB, INC. |
| K131132 | PELVIS II IMPLANT SYSTEM | May 31, 2013 | Substantially Equivalent | Stryker Trauma AG |
| K131093 | ORTHOLOC(R) 3DI ANKLE PLATING SYSTEM | May 21, 2013 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K130964 | GRIDLOCK PLATING SYSTEM | May 08, 2013 | Substantially Equivalent | TRILLIANT SURGICAL LTD |
| K130108 | DOUBLE ENGINE BONE PLATE AND SCREW SYSTEMS | Apr 19, 2013 | Substantially Equivalent | XIAMEN DOUBLE ENGINE MEDICAL MATERIAL CO., LTD |
| K130340 | LOCKING BONE PLATES AND SCREWS | Apr 05, 2013 | Substantially Equivalent | WEIGAO ORTHOPAEDIC DEVICE CO., LTD |
| K123241 | ARTHREX FRACTURE PLATES | Apr 05, 2013 | Substantially Equivalent | ARTHREX, INC. |
| K123562 | FLOWER SMALL AND MEDIUM BONE IMPLANTS | Mar 29, 2013 | Substantially Equivalent | FLOWER ORTHOPEDICS CORPORATION |
| K123964 | AXSOS 3 TI LOCKING PLATE SYSTEM | Mar 28, 2013 | Substantially Equivalent | Stryker Trauma AG |
| K122770 | BIOMET RECONSTRUCTIVE WEDGES MODEL 110003660-99, 110003797-831 | Mar 28, 2013 | Substantially Equivalent | BIOMET MANUFACTURING CORP. |
| K130009 | VARIAX 2 COMPRESSION PLATING SYSTEM | Mar 22, 2013 | Substantially Equivalent | Stryker Trauma AG |
| K123832 | OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC CLAVICLE PLATING SYSTEM, THE OIC SMALL FRAGME | Mar 20, 2013 | Substantially Equivalent | THE ORTHOPAEDIC IMPLANT COMPANY (OIC) |
| K123403 | AXSOS PROXIMAL LATERAL TIBIA LONG PLATES | Mar 20, 2013 | Substantially Equivalent | Stryker Trauma AG |
| K123875 | AAP RADIUS SET 2.5 | Mar 11, 2013 | Substantially Equivalent | AAP IMPLANTATE AG |
| K130116 | SUPERIOR LATERAL VARIAX CLAVICLE PLATE | Mar 05, 2013 | Substantially Equivalent | Stryker Trauma AG |
| K122936 | ANKLE TRAUMA SYSTEM | Feb 28, 2013 | Substantially Equivalent | ORTHOPRO LLC |
| K130061 | PICCOLO COMPOSITE PLATE SYSTEM | Feb 27, 2013 | Substantially Equivalent | CARBOFIX ORTHOPEDICS LTD. |
| K123525 | GRIDLOCK PLATING SYSTEM | Feb 15, 2013 | Substantially Equivalent | TRILLIANT SURGICAL LTD |
| K123918 | MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATE SYSTEM | Feb 14, 2013 | Substantially Equivalent | ZIMMER, INC. |
| K121826 | INTEGRA PROXIMAL HUMERAL PLATE SYSTEM | Feb 13, 2013 | Substantially Equivalent | ASCENSION ORTHOPEDICS, INC. |
| K123055 | SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATION | Jan 25, 2013 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K122310 | GEMINUS FOSSA SPECIFIC PLATE SYSTEM | Jan 18, 2013 | Substantially Equivalent | SKELETAL DYNAMICS, LLC |
| K102689 | CONVENTUS ORTHOPAEDICS FRACTURE FIXATION SYSTEM | Jan 17, 2013 | Substantially Equivalent | CONVENTUS ORTHOPAEDICS |
| K123000 | INTEGRA TOTAL FOOT SYSTEMS | Dec 21, 2012 | Substantially Equivalent | INTEGRA LIFESCIENCES CORPORATION |
| K123203 | MAXLOCK EXTREME SYSTEM MODEL MXL | Dec 14, 2012 | Substantially Equivalent | ORTHOHELIX SURGICAL DESIGNS, INC. |
| K121495 | LOQTEQ PROXIMAL HUMERUS PLATE 3.5, SHORT LOQTEQ PROXIMAL HUMERUS PLATE 3.5, LONG | Dec 07, 2012 | Substantially Equivalent | AAP IMPLANTATE AG |
| K122334 | CHECKMATE SMALL BONE FUSION SYSTEM | Nov 28, 2012 | Substantially Equivalent | ARTHROSURFACE, INC. |
| K120787 | MERETE LOCKING BONE PLATE SYSTEM III | Nov 27, 2012 | Substantially Equivalent | MERETE MEDICAL GMBH |
| K120651 | STABILIZ FIXATION SYSTEM | Nov 27, 2012 | Substantially Equivalent | STABILIZ ORTHOPAEDICS, LLC |
| K120409 | PICCOLO COMPOSITE PLATE SYSTEM | Nov 26, 2012 | Substantially Equivalent | CARBOFIX ORTHOPEDICS LTD. |
| K122538 | ACUMED PELVIC BONE PLATE SYSTEM | Nov 19, 2012 | Substantially Equivalent | ACUMED LLC |
| K121494 | LOQTEQ DISTAL LATERAL FEMUR PLATE 4.5 (LEFT AND RIGHT VERSION) LOQREQ CORTICAL SCREW 4.5 T25, SELF-TAPPING | Nov 19, 2012 | Substantially Equivalent | AAP IMPLANTATE AG |
| K122860 | KLS MARTIN RECON TALON | Nov 14, 2012 | Substantially Equivalent | KLS MARTIN L.P. |
| K113601 | AAP LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 SYSTEM | Nov 08, 2012 | Substantially Equivalent | AAP IMPLANTATE AG |
| K113602 | AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEM | Oct 31, 2012 | Substantially Equivalent | AAP IMPLANTATE AG |
| K122293 | PIONEER STERNAL CABLE PLATE SYSTEM | Oct 12, 2012 | Substantially Equivalent | PIONEER SURGICAL TECHNOLOGY, INC |
| K121651 | ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM | Oct 12, 2012 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K122737 | GEMINUS FOSSA SPECIFIC PLATE SYSTEM | Oct 03, 2012 | Substantially Equivalent | SKELETAL DYNAMICS, LLC |
| K122308 | AXSOS DISTAL LATERAL FEMUR TS LONG PLATES | Oct 01, 2012 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS |
| K121672 | AFT PROXIMAL HUMERUS FRACTURE PLATE | Oct 01, 2012 | Substantially Equivalent | SHOULDER OPTIONS, INC. |
| K121425 | ORTHOLOC 3DI ANKLE FUSION PLATING SYSTEM | Oct 01, 2012 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K122623 | SHORT LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT MODEL 3017-000 (LEFT) AND 3018-000 (RIGHT); 6 HOLE MEDIUM MIDSHAFT | Sep 26, 2012 | Substantially Equivalent | ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
| K121302 | BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM | Sep 19, 2012 | Substantially Equivalent | BIOMET MICROFIXATION |
| K122005 | MAXLOCK EXTREME SYSTEM | Sep 06, 2012 | Substantially Equivalent | ORTHOHELIX SURGICAL DESIGNS, INC. |
| K113648 | LOQTEQ LARGE FRAGMENT SET LOQTEQ CORTICAL SCREW 4.5, SMALL HEAD, T25, SELF TAPPING LOQTEQ CORTICAL SCREW 4.5, T25, SELF | Sep 06, 2012 | Substantially Equivalent | AAP IMPLANTATE AG |
| K113652 | LOQTEQ SMALL FRAGMENT SET LOQTEQ CORTICAL SCREW3.5, SMALL HEAD, T15, SELF TAPPING LOQTEQ CORTICAL SCREW 3.5, T15, SELF T | Aug 30, 2012 | Substantially Equivalent | AAP IMPLANTATE AG |
| K121452 | GRIDLOCK PLATING SYSTEM | Aug 20, 2012 | Substantially Equivalent | TRILLIANT SURGICAL LTD |
| K120016 | PIONEER STERNAL ASSIST IMPLANT SYSTEM | Jul 26, 2012 | Substantially Equivalent | PIONEER SURGICAL TECHNOLOGY, INC |
| K120903 | CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE | Jul 13, 2012 | Substantially Equivalent | ACUMED LLC |
| K121601 | SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE | Jul 06, 2012 | Substantially Equivalent | SYNTHES USA |
| K120854 | SYNTHES VA LCP ANKLE TRAUMA SYSTEM | Jun 18, 2012 | Substantially Equivalent | SYNTHES USA |
| K121437 | MINI MAXLOCK EXTREME PLATING SYSTEM | Jun 13, 2012 | Substantially Equivalent | ORTHOHELIX SURGICAL DESIGNS, INC. |
| K120772 | NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREWS, NCB CABLE BUTTON FOR NCB OPLYAXIAL LOCKING PLATE | Jun 12, 2012 | Substantially Equivalent | ZIMMER GMBH |
| K120689 | SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM | Jun 04, 2012 | Substantially Equivalent | SYNTHES (USA) PRODUCTS LLC |
| K120360 | ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS | May 29, 2012 | Substantially Equivalent | ORTHO SOLUTIONS LIMITED |
| K112794 | EOS SMALL BONE FIXATION SYSTEM | May 10, 2012 | Substantially Equivalent | TRIMED, INC. |
| K120717 | SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES) | May 08, 2012 | Substantially Equivalent | SYNTHES USA |
| K120359 | ORTHOLOC 3DI HALLUX SYSTEM | May 03, 2012 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K111008 | MICROWARE BONE PLATES AND BONE SCREW | May 02, 2012 | Substantially Equivalent | MICROWARE PRECISION CO., LTD. |
| K120108 | APTUS PROXIMAL HUMERUS SYSTEM | Apr 27, 2012 | Substantially Equivalent | MEDARTIS AG |
| K113760 | VARIAX SUPERIOR AND ANTERIOR, LATERAL AND MIDSHAFT CLAVICLE PLATES VARIAX AIMING BLOCKS & JOYSTICK | Apr 25, 2012 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS |
| K120015 | OSTEOMED WRIST PLATING SYSTEM | Apr 24, 2012 | Substantially Equivalent | OSTEOMED LP |
| K120818 | OTIS-C PLUS | Apr 19, 2012 | Substantially Equivalent | SCIENCE FOR BIOMATERIALS |
| K120157 | MINI MAXLOCK EXTREME PLATING SYSTEM | Apr 10, 2012 | Substantially Equivalent | ORTHOHELIX SURGICAL DESIGNS, INC. |
| K120667 | VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT | Apr 04, 2012 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K120802 | ORTHOLOC(TM) 3DI LOCKING SCREWS ORTHOLOC(TM) BONE SCREWS | Apr 02, 2012 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K112798 | LOCKING COMPRESSION PLATE SYSTEM | Mar 29, 2012 | Substantially Equivalent | SHANGHAI MICROPORT ORTHOPEDICS CO., LTD |
| K113733 | SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX | Mar 23, 2012 | Substantially Equivalent | NEOORTHO PRODUTOS ORTOPEDICOS S/A |
| K120070 | SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM | Mar 21, 2012 | Substantially Equivalent | SYNTHES USA |
| K112663 | ENHATCH ORTHOPAEDICS PATIENT/TECHNIQUE-SPECIFIC HUMERAL | Mar 12, 2012 | Substantially Equivalent | ENHATCH ORTHOPAEDICS LLC |
| K111663 | TRAUMA INTERNAL FIXATION SYSTEMS | Mar 12, 2012 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K110662 | ADAPTIVE WEDGE | Mar 12, 2012 | Substantially Equivalent | ADAPTIVE SPECIALTY, LLC |
| K113364 | 2.7MM LCP ULNA OSTEOTOMY SYSTEM | Feb 29, 2012 | Substantially Equivalent | SYNTHES (USA) PRODUCTS LLC |
| K120163 | ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM | Feb 17, 2012 | Substantially Equivalent | ACUTE INNOVATIONS LLC |
| K111678 | ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS | Feb 07, 2012 | Substantially Equivalent | ORTHO SOLUTIONS LIMITED |
| K113762 | CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM | Feb 06, 2012 | Substantially Equivalent | ARTHROSURFACE, INC. |
| K113014 | CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS | Jan 31, 2012 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K113048 | MAXLOCK EXTREME SYSTEM | Jan 30, 2012 | Substantially Equivalent | ORTHOHELIX SURGICAL DESIGNS, INC. |
| K113718 | NCB STRAIGHT NARROW SHAFT PLATES | Jan 27, 2012 | Substantially Equivalent | ZIMMER GMBH |
| K113318 | ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM | Jan 12, 2012 | Substantially Equivalent | ACUTE INNOVATIONS LLC |
| K113405 | SUSPENSION CLAVICLE FRACTURE REPAIR SYSTEM | Jan 11, 2012 | Substantially Equivalent | SUSPENSION ORTHOPAEDIC SOLUTIONS, LLC |
| K112169 | APTUS WRIST ARTHRODESIS PLATES | Jan 06, 2012 | Substantially Equivalent | MEDARTIS AG |
| K112923 | SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM | Dec 27, 2011 | Substantially Equivalent | SUSPENSION ORTHOPAEDIC SOLUTIONS, LLC |
| K113109 | STRYKER RESORBABLE FIXATION SYSTEM | Dec 23, 2011 | Substantially Equivalent | Stryker |
| K112926 | AXSOS LOCKING PLATE SYSTEM | Dec 19, 2011 | Substantially Equivalent | STRYKER CORP. |
| K112819 | RECONSTRUCTION LOCKING PLATE AND 3.5MM LOCKING SCREW | Dec 16, 2011 | Substantially Equivalent | XIAMEN DOUBLE ENGLINE MEDICAL MATERIAL CO., LTD |
| K112560 | APTUS(R) DISTAL HUMERUS SYSTEM | Dec 15, 2011 | Substantially Equivalent | MEDARTIS AG |
| K113339 | ORTHOLOC 3DSI LOCKING SCREWS | Dec 12, 2011 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K110700 | ASCENSION ATLAS HUMERAL PLATING SYSTEM | Dec 06, 2011 | Substantially Equivalent | ASCENSION ORTHOPEDICS, INC. |
| K112085 | SYNTHES LCP PEDIATRIC PLATE SYSTEMS | Nov 17, 2011 | Substantially Equivalent | SYNTHES (USA) PRODUCTS LLC |
| K112406 | PERI-LOC PROXIMAL FEMUR LOCKING BONE PLATES | Nov 14, 2011 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K112509 | TRIMED CLAVICLE FIXATION SYSTEM | Nov 04, 2011 | Substantially Equivalent | TRIMED, INC. |
| K112689 | SYNTHES STERNAL FIXATION SYSTEM | Oct 26, 2011 | Substantially Equivalent | SYNTHES INC |
| K112174 | NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM | Oct 26, 2011 | Substantially Equivalent | ZIMMER, INC. |
| K103513 | LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; MIDSHAFT SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; ANTERIOR CLAVICLE PLA | Oct 24, 2011 | Substantially Equivalent | ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
| K111419 | OSTEOMED HAND FUSION SYSTEM | Oct 07, 2011 | Substantially Equivalent | OSTEOMED L.P. |
| K111266 | EASYLOCK OSTEOSYSTEM | Oct 06, 2011 | Substantially Equivalent | TRIMED, INC. |
| K112455 | AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES | Sep 22, 2011 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS |
| K110086 | IFS PROFILE PLATES, SCREWS, AND WASHERS | Sep 09, 2011 | Substantially Equivalent | INTERNAL FIXATION SYSTEMS, INC. |
| K111620 | SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS | Aug 23, 2011 | Substantially Equivalent | SKELETAL DYNAMICS, LLC |
| K111432 | EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWS | Aug 19, 2011 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K102785 | TRIMED RADIOCARPAL FUSION SYSTEM | Aug 19, 2011 | Substantially Equivalent | TRIMED, INC. |
| K111540 | SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM | Aug 08, 2011 | Substantially Equivalent | SYNTHES (USA) |
| K110959 | ORTHOPEDIATRICS BLADE PLATE SYSTEM | Aug 05, 2011 | Substantially Equivalent | ORTHOPEDIATRICS, CORP |
| K111253 | ARTHREX DISTAL EXTREMITY PLATE SYSTEM | Aug 02, 2011 | Substantially Equivalent | ARTHREX, INC. |
| K110271 | MAESTRO WRIST PLATING SYSTEM | Jul 22, 2011 | Substantially Equivalent | BIOMET MANUFACTURING CORP. |
| K110320 | COMPREHENSIVEPROXIMAL HUMERAL PLATING SYSTEM | Jul 21, 2011 | Substantially Equivalent | BIOMET MANUFACTURING CORP. |
| K110201 | EXPLOR RADIAL HEAD PLATING SYSTEM | Jul 21, 2011 | Substantially Equivalent | BIOMET, INC. |
| K110670 | VLP FOOT TALUS PLATES, VLP PERCUTANEOUS CALCANEUS PLATES AND MISC VLP BONE SCREWS, PERI-LOC ANKLE FUSION PLATES | Jul 12, 2011 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K111326 | OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM | Jul 06, 2011 | Substantially Equivalent | GRAHAM MEDICAL TECHNOLOGIES, L.L.C. |
| K110908 | APTUS FOOT 3.5 SYSTEM | Jun 28, 2011 | Substantially Equivalent | MEDARTIS AG |
| K111086 | ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM | Jun 17, 2011 | Substantially Equivalent | ORTHOPEDIATRICS, CORP |
| K111041 | MINI VARIABLE SYSTEM | Jun 06, 2011 | Substantially Equivalent | ORTHOHELIX SURGICAL DESIGNS, INC. |
| K111039 | ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM | May 19, 2011 | Substantially Equivalent | ZIMMER, INC. |
| K110574 | BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM | May 18, 2011 | Substantially Equivalent | BIOMET MICROFIXATION, INC. |
| K102845 | MAHE FIXATION PLATE AND SCREW SYSTEM | May 13, 2011 | Substantially Equivalent | MAHE MEDICAL GMBH |
| K110125 | 2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM | Apr 21, 2011 | Substantially Equivalent | SYNTHES USA |
| K093914 | NEWDEAL COMPRESSION PLATES | Apr 14, 2011 | Substantially Equivalent | NEWDEAL SAS |
| K110476 | AXSOS (TM) LOCKING PLATE SYSTEM | Mar 18, 2011 | Substantially Equivalent | STRYKER CORP. |
| K101930 | MEMOMETAL NAVIS BONE PLATING SYSTEM | Mar 15, 2011 | Substantially Equivalent | MEMOMETAL TECHNOLOGIES |
| K102597 | PICCOLO COMPOSITE PLATE SYSTEM | Feb 24, 2011 | Substantially Equivalent | N.M.B. MEDICAL APPLICATIONS, LTD. |
| K110176 | AXSOS LOCKED PLATING 4.0MM LOCKING INSERTS | Feb 15, 2011 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS |
| K103332 | APTUS ULNA PLATES | Jan 24, 2011 | Substantially Equivalent | MEDARTIS AG |
| K103243 | 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM | Jan 21, 2011 | Substantially Equivalent | SYNTHES (USA) |
| K102998 | CONGRUENT BONE PLATE SYSTEM | Jan 04, 2011 | Substantially Equivalent | ACUMED LLC |
| K103408 | POSTERIOR LATERAL PLATES | Dec 16, 2010 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K102201 | CONTOURS LAPIDUS PLATING SYSTEM | Dec 15, 2010 | Substantially Equivalent | ORTHOFIX INC. |
| K102537 | APTUS 1.5 TRILOCK | Dec 10, 2010 | Substantially Equivalent | MEDARTIS AG |
| K102694 | 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES | Dec 09, 2010 | Substantially Equivalent | SYNTHES (USA) |
| K102282 | THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES | Dec 07, 2010 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS |
| K102095 | SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM | Dec 07, 2010 | Substantially Equivalent | SUSPENSION ORTHOPAEDIC SOLUTIONS, LLC |
| K102352 | EVOLVE EPS ORTHOLOC | Dec 02, 2010 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K102505 | HTO PLATING SYSTEM | Nov 24, 2010 | Substantially Equivalent | AESCULAP IMPLANT SYSTEMS, LLC |
| K102429 | ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREW | Nov 23, 2010 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K101400 | LOCKING COMPRESSION PLATE | Nov 09, 2010 | Substantially Equivalent | CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. |
| K100944 | CLAVICLE LOCKING PLATE SYSTEM | Oct 22, 2010 | Substantially Equivalent | NEWCLIP TECHNICS |
| K101936 | CONTOURS VSP III VOLAR PLATING SYSTEM | Oct 20, 2010 | Substantially Equivalent | ORTHOFIX, INC. |
| K100123 | ACUMED WRIST ARTHRODESIS PLATE SYSTEM | Oct 06, 2010 | Substantially Equivalent | ACUMED LLC |
| K102156 | MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWS | Sep 30, 2010 | Substantially Equivalent | ORTHOHELIX SURGICAL DESIGNS, INC. |
| K101962 | MINI MAXLOCK EXTREME PLATING SYSTEM | Sep 27, 2010 | Substantially Equivalent | ORTHOHELIX SURGICAL DESIGNS, INC. |
| K101536 | 2.7/3.5MM VA-LCP ANTERIRO CLAVICLE PLATE SYSTEM | Sep 15, 2010 | Substantially Equivalent | SYNTHES (USA) LLC |
| K093868 | I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM | Aug 05, 2010 | Substantially Equivalent | I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
| K100776 | SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM | Aug 03, 2010 | Substantially Equivalent | SYNTHES (USA) |
| K100502 | ASCENSION TOTAL PLATE SYSTEM | Aug 02, 2010 | Substantially Equivalent | ASCENSION ORTHOPEDICS, INC. |
| K101240 | CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467 | Jul 23, 2010 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K092889 | SYNTEC OSTEO-PLATE AND SCREW FIXATION | Jun 25, 2010 | Substantially Equivalent | SYNTEC SCIENTIFIC CORP. |
| K100176 | ASCENSION ANKLE FUSION PLATE SYSTEM | Jun 16, 2010 | Substantially Equivalent | ASCENSION ORTHOPEDICS, INC. |
| K101421 | MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708; 851318704-708, 131218204 | Jun 15, 2010 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K100604 | OTIS -C PLUS | Jun 14, 2010 | Substantially Equivalent | SCIENCES ET BIO MATERIAUX (SBM) |
| K092528 | BIOMET FORERUNNER LOCKING PLATE SYSTEM | May 21, 2010 | Substantially Equivalent | BIOMET TRAUMA (AKA EBI, LP) |
| K100240 | ORTHOPEDIATRICS PEDILOC TIBIA PLATE SYSTEM | May 17, 2010 | Substantially Equivalent | ORTHOPEDIATRICS, CORP. |
| K100271 | VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES | May 14, 2010 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K101056 | VARIAX ELBOW SYSTEM | May 13, 2010 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K093978 | EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM | May 11, 2010 | Substantially Equivalent | EXACTECH, INC. |
| K092812 | SYNTHES (USA) 2.7MM/ 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATES | May 11, 2010 | Substantially Equivalent | SYNTHES (USA) |
| K100475 | AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 5MM LOCKING INSERTS | Apr 30, 2010 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K100618 | MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY | Apr 20, 2010 | Substantially Equivalent | ORTHOHELIX SURGICAL DESIGNS, INC. |
| K093880 | PEANUT GROWTH CONTROL PLATING SYSTEM | Apr 16, 2010 | Substantially Equivalent | EBI, L.P. |
| K100111 | NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM | Apr 12, 2010 | Substantially Equivalent | ZIMMER INC. |
| K090975 | DEROYAL NON-LOCKING BONE FIXATION SYSTEM | Apr 12, 2010 | Substantially Equivalent | DEROYAL INDUSTRIES, INC. |
| K100676 | SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL | Apr 08, 2010 | Substantially Equivalent | SYNTHES (USA) |
| K093928 | SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES | Mar 29, 2010 | Substantially Equivalent | SYNTHES (USA) |
| K093772 | SYNTHES STERNAL FIXATION SYSTEM | Mar 29, 2010 | Substantially Equivalent | SYNTHES |
| K092493 | GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM | Mar 29, 2010 | Substantially Equivalent | GPC MEDICAL LTD |
| K093983 | SMPLE PLATE AND SCREWS | Mar 19, 2010 | Substantially Equivalent | BIOMET TRAUMA (AKA EBI, LP) |
| K094037 | TC PLATING SYSTEM | Mar 10, 2010 | Substantially Equivalent | ORTHO-PRO LLC |
| K093761 | OPTILOCK VL (VARIABLE ANGLE LOCKING) DISTAL RADIUS PLATING SYSTEM | Mar 05, 2010 | Substantially Equivalent | BIOMET TRAUMA (AKA EBI, LP) |
| K093900 | EDGELOCK | Feb 17, 2010 | Substantially Equivalent | ORTHOHELIX SURGICAL DESIGNS, INC. |
| K091493 | ORTHO SELECT BONE PLATES AND SCREW SYSTEM | Feb 05, 2010 | Substantially Equivalent | ORTHO SELECT IMPLANT TECHNOLOGY GESELLSCHAFT |
| K100146 | EVOLVE EPS ORTHOLOC | Feb 02, 2010 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K093474 | DEPUY FRACTURE AND FUSION PLATING SYSTEM | Feb 02, 2010 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K093433 | VARIAX ELBOW SYSTEM PLATE LINE EXTENSION | Jan 28, 2010 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K093950 | BIOFOAM BONE WEDGE MODEL ASSORTED | Jan 22, 2010 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K093781 | MODIFIED: NEWDEAL HALLU PLATES | Jan 22, 2010 | Substantially Equivalent | NEWDEAL SAS |
| K091644 | SYNTHES (USA) 2.4MM LCP VOLAR COLUMN DISTAL RADIUS PLATES | Dec 23, 2009 | Substantially Equivalent | SYNTHES (USA) |
| K093163 | INTEGRA TOTAL WRIST FUSION SYSTEM | Dec 15, 2009 | Substantially Equivalent | INTEGRA LIFESCIENCES CORPORATION |
| K092178 | AXSOS STRYKER LOCKED PLATING SYSTEM LINE EXTENSION OF CABLE PLUGS | Nov 20, 2009 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K092670 | BIODRIVE MICRO SCREW SYSTEM | Nov 19, 2009 | Substantially Equivalent | EBI,LLC D/B/A BIOMET TRAUMA |
| K092609 | SYNTHES 3.5 MM AND 4.55 MM CURVED NARROW AND BROAD LOCKING COMPRESSION PLATES (LCP) | Nov 17, 2009 | Substantially Equivalent | SYNTHES (USA) |
| K092556 | SYNTHES (USA) 2.4MM VA-LCP TWO-COLUMN NARROW VOLAR DISTAL RADIUS | Nov 17, 2009 | Substantially Equivalent | SYNTHES (USA) |
| K082399 | PECTUS STRUT | Nov 05, 2009 | Substantially Equivalent | KOROS USA, INC. |
| K092317 | DEROYAL NON-STERILE LOCKING COMPRESSION PLATE SYSTEM | Nov 02, 2009 | Substantially Equivalent | DEROYAL INDUSTRIES, INC. |
| K092381 | IBALANCE AKRFX MEDIAL OPENING WEDGE TIBIAL SYSTEM, IFX MEDIAL PEEK IMPLANT AND ANCHOR, AKRFX INSTRUMENTATION | Oct 27, 2009 | Substantially Equivalent | IBALANCE MEDICAL, INC. |
| K090139 | ANKLE ARTHRODESIS PLATE SYSTEM | Oct 27, 2009 | Substantially Equivalent | TORNIER, INC. |
| K092247 | SYNTHES LOCKING HAND PLATES | Sep 25, 2009 | Substantially Equivalent | SYNTHES (USA) |
| K092671 | VARIAX ELBOW SYSTEM LINE EXTENSION | Sep 23, 2009 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K091614 | OSTEOMED FOOT PLATING SYSTEM | Sep 10, 2009 | Substantially Equivalent | OSTEOMED L.P. |
| K092419 | AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 3MM LOCKING INSERTS | Sep 01, 2009 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K090304 | WAVEON WRX BONE FIXATION SYSTEM | Aug 28, 2009 | Substantially Equivalent | SONOMA ORTHOPEDIC PRODUCTS, INC. |
| K092078 | OPTILOCK PERIARTICULAR PLATING | Aug 05, 2009 | Substantially Equivalent | BIOMET TRAUMA |
| K092015 | PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM | Jul 30, 2009 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K091294 | LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE, | Jul 24, 2009 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K091058 | ADKINS STRUT | Jul 22, 2009 | Substantially Equivalent | BIOMET MICROFIXATION, INC. |
| K091156 | TRIMED STERILE PRODUCT | Jul 15, 2009 | Substantially Equivalent | TRIMED, INC. |
| K091479 | APTUS FOOT SYSTEM | Jul 13, 2009 | Substantially Equivalent | MEDARTIS AG |
| K083154 | NEWDEAL HALLU LOCK PLATE SYSTEM | Jul 10, 2009 | Substantially Equivalent | NEWDEAL SAS |
| K090582 | CALCANEAL FRACTURE PLATE SYSTEM | Jul 02, 2009 | Substantially Equivalent | TORNIER, INC. |
| K090522 | OSTEOMED HAND PLATE AND SCREW FIXATION SYSTEM | Jul 02, 2009 | Substantially Equivalent | OSTEOMED L.P. |
| K090983 | APTUS 2.0/2.3 FOUR CORNER FUSION PLATE | Jul 01, 2009 | Substantially Equivalent | MEDARTIS AG |
| K091609 | NEWDEAL COMPRESSION PLATE | Jun 30, 2009 | Substantially Equivalent | NEWDEAL SAS |
| K091243 | ORTHOLOC ANKLE PLATING SYSTEM (APS) | Jun 26, 2009 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K090877 | PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND MULTIDIRECTIONAL SCREWS | Jun 26, 2009 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K090786 | KENS INTERNAL FIXATION SYSTEM | Jun 18, 2009 | Substantially Equivalent | KENS FINEMEDTECH SDN. BHD |
| K090289 | CLAVICLE PLATING SYSTEM | Jun 15, 2009 | Substantially Equivalent | ORTHOHELIX SURGICAL DESIGNS, INC. |
| K090675 | SMITH & NEPHEW, INC. VLP FOOT PLATING, SCREW SYSTEM AND ACCESSORIES | Jun 04, 2009 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K090440 | HINGE PEDIATRIC PLATING SYSTEM | May 20, 2009 | Substantially Equivalent | PEGA MEDICAL INC. |
| K090692 | ORTHOLOC 2.0/2.4 PLATE SYSTEM | May 08, 2009 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K090839 | MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCREW IMPLANTS | Apr 24, 2009 | Substantially Equivalent | SYNTEC SCIENTIFIC CORP. |
| K090666 | PEDIPLATES | Apr 24, 2009 | Substantially Equivalent | ORTHOPEDIATRICS, CORP. |
| K090053 | APTUS 2.0 RADIAL HEAD SYSTEM | Apr 23, 2009 | Substantially Equivalent | MEDARTIS AG |
| K090047 | SYNTHES (USA) 1.5MM MINI FRAGMENT LCP SYSTEM | Apr 01, 2009 | Substantially Equivalent | SYNTHES (USA) |
| K090492 | 1.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCREWS | Mar 31, 2009 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K083843 | LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM | Mar 20, 2009 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K083694 | SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES | Mar 06, 2009 | Substantially Equivalent | SYNTHES (USA) |
| K083573 | SYNTHES (USA) 3.5MM LOCKING ATTACHMENT PLATES | Mar 04, 2009 | Substantially Equivalent | SYNTHES (USA) |
| K083654 | ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM TI-6A1-4V ALLOY, CP GRADE TITANIUM) | Feb 26, 2009 | Substantially Equivalent | ZIMMER, INC. |
| K082300 | ANATOMIC LOCKING PLATING SYSTEM | Feb 18, 2009 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K083447 | MEMOMETAL ANCHORAGE BONE PLATE SYSTEM, MODELS PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50 | Feb 06, 2009 | Substantially Equivalent | MEMOMETAL TECHNOLOGIES |
| K083286 | ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEM | Jan 30, 2009 | Substantially Equivalent | ORTHOPEDIATRICS, CORP. |
| K083025 | SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR SYSTEM | Jan 14, 2009 | Substantially Equivalent | SYNTHES (USA) |
| K083032 | PERI-LOC BONE PLATING AND SCREW SYSTEM | Jan 07, 2009 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K083213 | SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES | Dec 30, 2008 | Substantially Equivalent | SYNTHES (USA) |
| K081608 | PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS) | Dec 19, 2008 | Substantially Equivalent | TOBY ORTHOPAEDICS, LLC |
| K082527 | ZIMMER UNIVERSAL LOCKING SYSTEM: 3.5 MM LOCKING PLATES AND SCREWS | Dec 18, 2008 | Substantially Equivalent | ZIMMER, INC. |
| K082625 | SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES | Dec 17, 2008 | Substantially Equivalent | SYNTHES (USA) |
| K083364 | 2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424 | Dec 11, 2008 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K072562 | MICROWARE BONE PLATES AND BONE SCREWS | Dec 04, 2008 | Substantially Equivalent | MICROWARE PRECISION CO., LTD. |
| K082807 | SYNTHES (USA) 3.5 AND 4.5 MM LOCKING COMPRESSION PLATE SYSTEM WITH EXPANDED INDICATIONS | Nov 24, 2008 | Substantially Equivalent | SYNTHES (USA) |
| K082624 | SYNTHES (USA) 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATES | Nov 10, 2008 | Substantially Equivalent | SYNTHES (USA) |
| K082072 | SYNTHES (USA) 3.5MM LCP HOOK PLATE | Nov 07, 2008 | Substantially Equivalent | SYNTHES (USA) |
| K082078 | ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM: DISTAL HUMERAL AND PROXIMAL ULNA PLATES | Nov 03, 2008 | Substantially Equivalent | ZIMMER, INC. |
| K081759 | NCB POLYAXIAL LOCKING PLATE SYSTEM, PROXIMAL HUMERAL PLATES, ZIMMER UNIVERSAL LOCKING SYSTEM, 3.5MM TIVANIUM TI-6AL-4V | Oct 16, 2008 | Substantially Equivalent | ZIMMER GMBH |
| K081374 | CHARLOTTE LISFRANC BONE SCREW, CHARLOTTE LISFRANC PLATE | Sep 09, 2008 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K081623 | SYNTHES RIB FIXATION SYSTEM | Sep 08, 2008 | Substantially Equivalent | SYNTHES (USA) |
| K080992 | AESCULAP IMPLANT SYSTEMS HIGH TIBIAL OSTEOTOMY PLATING SYSTEM | Sep 04, 2008 | Substantially Equivalent | AESCULAP IMPLANT SYSTEMS, INC. |
| K081588 | RE-ZORB PLATING SYSTEM | Sep 03, 2008 | Substantially Equivalent | ACUTE INNOVATIONS LLC |
| K081546 | SMALL BONE LOCKING PLATING SYSTEM | Aug 26, 2008 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K073432 | TRAUSON BONE PLATE | Aug 13, 2008 | Substantially Equivalent | TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD. |
| K081353 | SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEMUR PLATES | Jul 23, 2008 | Substantially Equivalent | SYNTHES (USA) |
| K081407 | ORTHOPEDIATRICS PEDIPLATES SYSTEM | Jul 22, 2008 | Substantially Equivalent | ORTHOPEDIATRICS, CORP. |
| K073115 | ORTHOMESH | Jul 15, 2008 | Substantially Equivalent | SYNTHES (USA) |
| K081373 | EVOLVE EPS SYSTEM | Jul 03, 2008 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K073556 | MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS | Jun 24, 2008 | Substantially Equivalent | MEDXPERT GMBH |
| K081106 | PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM VOLAR DISTAL RADIUS LOCKING PLATE FOR THE UPPER EXTREMITY-ASTM F139 | Jun 18, 2008 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K080522 | SYNTHES 3.5 MM LCP DISTAL TIBIA T PLATES | May 23, 2008 | Substantially Equivalent | SYNTHES (USA) |
| K080184 | DISTAL HUMERAL PLATES WITH ANGULAR STABILITY | Mar 26, 2008 | Substantially Equivalent | I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
| K073624 | MODULAR FOOT SYSTEM | Mar 20, 2008 | Substantially Equivalent | ORTHOHELIX SURGICAL DESIGNS, INC. |
| K072411 | AAP BONE PLATES AND SCREW IMPLANTS | Mar 20, 2008 | Substantially Equivalent | AAP IMPLANTATE AG |
| K080667 | VARIAX DISTAL RADIUS TORX SCREWS | Mar 19, 2008 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K073228 | DC ULNAR SHORTENING SYSTEM | Feb 29, 2008 | Substantially Equivalent | ORTHOPRO LLC |
| K080295 | CHARLOTTE CLAW 3.5 | Feb 27, 2008 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K073460 | SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES | Feb 21, 2008 | Substantially Equivalent | SYNTHES (USA) |
| K073375 | NEWDEAL TIBIAXYS SYSTEM | Feb 21, 2008 | Substantially Equivalent | NEWDEAL SAS |
| K071809 | ENSPLINTRX BONE FIXATION SYSTEM | Feb 21, 2008 | Substantially Equivalent | SONOMA ORTHOPEDIC PRODUCTS, INC. |
| K073344 | ORTHOPEDIATRICS PLATING SYSTEM | Feb 19, 2008 | Substantially Equivalent | ORTHOPEDIATRICS, LLC |
| K073535 | BIOFOAM BONE WEDGE | Jan 07, 2008 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K073186 | SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM | Dec 17, 2007 | Substantially Equivalent | SYNTHES (USA) |
| K072832 | ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM | Dec 14, 2007 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K072818 | PERI-LOC PERIARTRICULAR LCK PIT SYS-PROX FEM PLATES/SCREWS.CALBE ACCESS | Nov 19, 2007 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K072740 | MONDEAL EXTREMITY BONE FIXATION SYSTEM | Nov 19, 2007 | Substantially Equivalent | MONDEAL MEDICAL SYSTEMS GMBH |
| K072423 | 4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY. | Nov 07, 2007 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K072083 | SMALL FRAGMENT LOCKING PLATING SYSTEM | Oct 25, 2007 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K070592 | SMALL BONE WEDGE | Oct 05, 2007 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K071798 | MONDEAL DISTAL RADIUS SYSTEM | Sep 17, 2007 | Substantially Equivalent | MONDEAL MEDICAL SYSTEMS GMBH |
| K071797 | MONDEAL HAND CONTOUR SYSTEM | Sep 17, 2007 | Substantially Equivalent | MONDEAL MEDICAL SYSTEMS GMBH |
| K071577 | BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER | Sep 06, 2007 | Substantially Equivalent | BIOMET MICROFIXATION, INC. |
| K072175 | TITANIUM HIP TOOL LOCKING PLATE | Aug 21, 2007 | Substantially Equivalent | ORTHOPEDIC SCIENCES, INC |
| K071563 | PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM | Aug 08, 2007 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K071549 | SBI RHEAD PLATING SYSTEM | Aug 07, 2007 | Substantially Equivalent | SMALL BONE INNOVATIONS INC. |
| K071105 | OSTEOMED CALCANEAL PLATE AND SCREW FIXATION SYSTEM | Jul 30, 2007 | Substantially Equivalent | OSTEOMED L.P. |
| K063275 | DISTAL CLAVICULAR FRAGMENT IMMOBILIZATION PLATE LEFT, MODEL 1810-116_126-03 (05,07) RIGHT 1811-116_126-03 (05,07) | Jul 27, 2007 | Substantially Equivalent | TERRAY CORP. |
| K071325 | BIOMET VARIABLE LOCKING PLATE SYSTEM | Jul 26, 2007 | Substantially Equivalent | BIOMET TRAUMA |
| K071715 | ACUMED CONGRUENT BONE PLATE SYSTEM | Jul 18, 2007 | Substantially Equivalent | ACUMED LLC |
| K071264 | SYNTHES (USA) 2.4/2.7 MM LOCKING FOOT MODULE | Jul 09, 2007 | Substantially Equivalent | SYNTHES (USA) |
| K071184 | SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS SYSTEM | Jun 22, 2007 | Substantially Equivalent | SYNTHES (USA) |
| K070946 | SYNTHES LCP DIAPHYSEAL-METAPHYSEAL (DIA-META) VOLAR DISTAL RADIUS PLATES | Jun 06, 2007 | Substantially Equivalent | SYNTHES (USA) |
| K070793 | SBI DISTAL RADIUS VOLAR PLATING SYSTEM | May 30, 2007 | Substantially Equivalent | SMALL BONE INNOVATIONS INC. |
| K070823 | GROWTH CONTROL PLATING SYSTEM | May 07, 2007 | Substantially Equivalent | BIOMET TRAUMA |
| K070447 | NEWDEAL COMPRESSION PLATE | Mar 29, 2007 | Substantially Equivalent | NEWDEAL SAS |
| K070208 | SYNTHES 4.5 MM LCP POSTEROLATERAL PROXIMAL FEMUR PLATES | Mar 28, 2007 | Substantially Equivalent | SYNTHES (USA) |
| K070169 | KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILE | Mar 26, 2007 | Substantially Equivalent | KLS MARTIN L.P. |
| K063875 | STRYKER FOOT PLATING SYSTEM | Mar 15, 2007 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K063726 | PLC SUTURE ANCHOR | Mar 06, 2007 | Substantially Equivalent | SMITH & NEPHEW INC., ENDOSCOPY DIV. |
| K070170 | DALL-MILES SYSTEM | Mar 02, 2007 | Substantially Equivalent | STRYKER ORTHOPAEDICS |
| K070241 | MODIFICATION TO LAPIDUS PLATE | Feb 08, 2007 | Substantially Equivalent | NEWDEAL S.A. |
| K070160 | MODIFICATION TO TTC PLATES | Feb 08, 2007 | Substantially Equivalent | NEWDEAL S.A. |
| K063820 | LISFRANC PLATE | Feb 08, 2007 | Substantially Equivalent | NEWDEAL S.A. |
| K063831 | BASAL DORSAL PLATES | Feb 07, 2007 | Substantially Equivalent | NEWDEAL SAS |
| K063672 | FIBULA PLATE PROLOCK WITH ANGULAR STABILITY | Feb 02, 2007 | Substantially Equivalent | I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
| K063410 | INION CPS/OTPS FREEDOMPLATE | Jan 23, 2007 | Substantially Equivalent | INION LTD. |
| K063709 | TS-BONE HIP TOOL | Jan 04, 2007 | Substantially Equivalent | ORTHOPEDIC SCIENCES, INC |
| K063009 | FLEXIGRIP STERNAL CLOSURE SYSTEM, MODEL FG0200 THROUGH FG0400 (NONE SIZES) | Dec 27, 2006 | Substantially Equivalent | PRAESIDIA S.R.L. |
| K063166 | I.T.S. PELVIC RECONSTRUCTION SYSTEM | Dec 22, 2006 | Substantially Equivalent | I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
| K063095 | HUMERUS LOCKING PLATING SYSTEM | Dec 22, 2006 | Substantially Equivalent | NEWCLIP TECHNICS |
| K063506 | LORENZ STERNAL CLOSURE SYSTEM | Dec 18, 2006 | Substantially Equivalent | WALTER LORENZ SURGICAL, INC. |
| K063049 | SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEM | Dec 18, 2006 | Substantially Equivalent | SYNTHES (USA) |
| K063020 | INTAI BONE PLATE AND BONE SCREW SYSTEM; INTAI DHS/DCS PLATE SYSTEM | Dec 14, 2006 | Substantially Equivalent | INTAI TECHNOLOGY INC. |
| K063460 | ACUMED CONGRUENT BONE PLATE SYSTEM | Dec 07, 2006 | Substantially Equivalent | ACUMED LLC |
| K063303 | UNIVERSAL LOCKING SYSTEM, 2.7MM PLATES & SCREWS | Nov 22, 2006 | Substantially Equivalent | ZIMMER, INC. |
| K063033 | MODIFICATION TO TITANIUM SHOULDER PLATE IMPLANT | Nov 01, 2006 | Substantially Equivalent | ORTHOPEDIC SCIENCES, INC |
| K062498 | PROFYLE SYSTEM | Oct 25, 2006 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K062903 | SBI CARPAL FUSION PLATE | Oct 20, 2006 | Substantially Equivalent | SMALL BONE INNOVATIONS INC. |
| K062564 | SYNTHES LCP DISTAL FEMUR PLATES | Oct 19, 2006 | Substantially Equivalent | SYNTHES (USA) |
| K062494 | EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM | Oct 19, 2006 | Substantially Equivalent | EBI, L.P. |
| K062747 | ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM | Sep 29, 2006 | Substantially Equivalent | ARTHREX, INC. |
| K062216 | PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM | Sep 15, 2006 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K061973 | SYNTHES 3.5MM SPRING PLATE | Sep 11, 2006 | Substantially Equivalent | SYNTHES (USA) |
| K061940 | SYNTHES LCP ANKLE ARTHRODESIS PLATES | Sep 08, 2006 | Substantially Equivalent | SYNTHES (USA) |
| K051165 | KLS MARTIN STERNAL TALON | Sep 07, 2006 | Substantially Equivalent | KLS-MARTIN L.P. |
| K061917 | DISTAL RADIUS LOCKING PLATING SYSTEM | Aug 28, 2006 | Substantially Equivalent | NEWCLIP TECHNICS |
| K061808 | DARCO LOCKING BONE PLATE SYSTEM | Aug 17, 2006 | Substantially Equivalent | DARCO INTERNATIONAL, INC. |
| K061955 | RAYHACK LOW PROFILE LOCKING PLATE AND INSTRUMENTS | Aug 04, 2006 | Substantially Equivalent | CREATIVE MEDICAL DESIGNS, INC. |
| K061753 | SYNTHES (USA) CLAVICLE HOOK PLATES | Aug 04, 2006 | Substantially Equivalent | SYNTHES (USA) |
| K060474 | LISFRANC PLATE | Aug 03, 2006 | Substantially Equivalent | NEWDEAL S.A. |
| K053624 | MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM | Jul 17, 2006 | Substantially Equivalent | MEDICON, E.G. |
| K061400 | CALCANEAL TRAUMA SYSTEM | Jun 29, 2006 | Substantially Equivalent | ORTHOHELIX SURGICAL DESIGNS, INC. |
| K061211 | NCB PLATING SYSTEM, PROXIMAL TIBIA PLATES | Jun 14, 2006 | Substantially Equivalent | ZIMMER GMBH |
| K061352 | PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM FOR THE UPPER EXTREMITY | Jun 08, 2006 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K061384 | LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUM | Jun 06, 2006 | Substantially Equivalent | WALTER LORENZ SURGICAL, INC. |
| K061098 | EBI OPTILOCK PERIARTICULAR PLATING SYSTEM | May 24, 2006 | Substantially Equivalent | EBI, L.P. |
| K061012 | AXSOS PLUS LOCKING PLATE SYSTEM | May 19, 2006 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K060476 | LAPIDUS PLATE | May 17, 2006 | Substantially Equivalent | NEWDEAL S.A. |
| K060473 | TTC PLATE | May 17, 2006 | Substantially Equivalent | NEWDEAL S.A. |
| K060969 | POLYAX LOCKED PLATING SYSTEM | May 12, 2006 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K060798 | STRYKER PLATING SYSTEM | Apr 12, 2006 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K060294 | DIAPHYSEAL PLATE | Mar 22, 2006 | Substantially Equivalent | HAND INNOVATIONS, LLC. |
| K060156 | STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW SYSTEM | Mar 20, 2006 | Substantially Equivalent | I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
| K060514 | STRYKER PLATING SYSTEM | Mar 17, 2006 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP |
| K053182 | DRLOCK DISTAL RADIUS VOLAR SYSTEM | Feb 27, 2006 | Substantially Equivalent | ORTHOHELIX SURGICAL DESIGNS, INC. |
| K060041 | TRIMED BONE PLATES | Feb 07, 2006 | Substantially Equivalent | TRIMED, INC. |
| K053408 | NEXA BONE PLATE AND SCREW SYSTEM | Dec 22, 2005 | Substantially Equivalent | NEXA ORTHOPEDICS, INC. |
| K052901 | ARTHREX TENSIONLOK | Dec 12, 2005 | Substantially Equivalent | ARTHREX, INC. |
| K052683 | SYNTHES (USA) STERNAL FIXATION SYSTEM | Dec 05, 2005 | Substantially Equivalent | SYNTHES (USA) |
| K052624 | INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE | Nov 16, 2005 | Substantially Equivalent | INION LTD. |
| K052041 | COLLAGEN BONE HEALING PROTECTIVE SHEET | Oct 25, 2005 | Substantially Equivalent | COLLAGEN MATRIX, INC. |
| K052294 | SHOULDER NAIL PLATE | Oct 21, 2005 | Substantially Equivalent | HAND INNOVATIONS, LLC. |
| K052368 | OLECRANONPLATE WITH ANGULAR STABILITY | Oct 17, 2005 | Substantially Equivalent | I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
| K052677 | SYNTHES UNIVERSAL LOCKING TROCHANTER STABILIZATION PLATE (ULTSP) | Oct 12, 2005 | Substantially Equivalent | SYNTHES (USA) |
| K052538 | S-BONE HIP TOOL | Oct 07, 2005 | Substantially Equivalent | ORTHOPEDIC SCIENCES, INC |
| K052390 | SYNTHES LCP PROXIMAL TIBIA PLATES LINE EXTENSION | Oct 07, 2005 | Substantially Equivalent | SYNTHES (USA) |
| K052614 | LOW PROFILE PLATE AND SCREW SYSTEM | Sep 28, 2005 | Substantially Equivalent | ARTHREX, INC. |
| K052248 | DORSAL NAIL PLATE, ANATOMICAL | Sep 14, 2005 | Substantially Equivalent | HAND INNOVATIONS, LLC. |
| K052152 | B-BOP PLATE | Sep 13, 2005 | Substantially Equivalent | NEWDEAL S.A. |
| K052150 | VOLAR PLATE SYSTEM | Sep 08, 2005 | Substantially Equivalent | DVO EXTREMITY SOLUTIONS, LLC |
| K051986 | SYNTHES 4.5 MM LCP STRAIGHT RECONSTRUCTION PLATES | Sep 08, 2005 | Substantially Equivalent | SYNTHES (USA) |
| K051945 | MIOT PLATING SYSTEM | Sep 06, 2005 | Substantially Equivalent | ORTHOFIX SRL |
| K051747 | SBI WRISTFIT | Sep 06, 2005 | Substantially Equivalent | SMALL BONE INNOVATIONS, LLC |
| K051567 | APTUS TITANIUM OSTEOSYNTHESIS SYSTEM | Aug 23, 2005 | Substantially Equivalent | MEDARTIS, INC. |
| K052011 | PILONPLATE WITH ANGULAR STABILITY | Aug 10, 2005 | Substantially Equivalent | I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
| K051908 | CHARLOTTE COMPRESSION PLATE | Aug 10, 2005 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K050657 | MONDEAL CONTOUR HO SYSTEM | Aug 08, 2005 | Substantially Equivalent | KAPP SURGICAL INSTRUMENT, INC. |
| K050655 | MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005 | Aug 08, 2005 | Substantially Equivalent | KAPP SURGICAL INSTRUMENT, INC. |
| K051884 | CHARLOTTE SMALL MTP FUSION PLATE | Aug 05, 2005 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K050681 | OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLATES | Jul 27, 2005 | Substantially Equivalent | TRIMED, INC. |
| K051410 | ACUMED RIB CONGRIENT BONE PLATE SYSTEM | Jul 21, 2005 | Substantially Equivalent | ACUMED LLC |
| K051735 | PERI-LOC LOCKING BONE PLATES AND LOCKING BONE SCREWS FOR THE UPPER EXTREMITY | Jul 19, 2005 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K051412 | HUMERAL HEAD PLATE WITH ANGULAR STABILITY | Jul 11, 2005 | Substantially Equivalent | I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
| K051155 | SOLCO 4CIS GENERAL PLATE SYSTEM | Jul 11, 2005 | Substantially Equivalent | SOLCO BIOMEDICAL CO., LTD. |
| K050852 | CLAVICULAPLATE WITH ANGULAR STABLITY BONE PLATE SYSTEM | Jun 22, 2005 | Substantially Equivalent | I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
| K050868 | MAXLOCK | May 27, 2005 | Substantially Equivalent | ORTHOHELIX SURGICAL DESIGNS, INC. |
| K051181 | CUSTOM-HIP TOOL | May 23, 2005 | Substantially Equivalent | ORTHOPEDIC SCIENCES, INC |
| K051032 | TITANIUM-HIP TOOL | May 23, 2005 | Substantially Equivalent | ORTHOPEDIC SCIENCES, INC |
| K051083 | ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEM | May 12, 2005 | Substantially Equivalent | ACUMED LLC |
| K050646 | SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES | Apr 26, 2005 | Substantially Equivalent | SYNTHES (USA) |
| K050462 | SBI HAND FIXATION SYSTEM (TM) | Apr 26, 2005 | Substantially Equivalent | SMALL BONE INNOVATIONS LLC |
| K050101 | THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10 | Apr 15, 2005 | Substantially Equivalent | ZIMMER TRABECULAR |
| K050607 | SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO) | Apr 11, 2005 | Substantially Equivalent | SYNTHES (USA) |
| K050512 | STRYKER LOCKED PLATING SYSTEM | Mar 21, 2005 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K050492 | INTEGRA BONE FIXATION SYSTEM | Mar 14, 2005 | Substantially Equivalent | INTEGRA LIFESCIENCES CORP. |
| K050110 | SYNTHES (USA) LCP MODULAR FOOT PLATES | Mar 04, 2005 | Substantially Equivalent | SYNTHES (USA) |
| K050121 | ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM, MODEL 2357 & 2359 | Jan 31, 2005 | Substantially Equivalent | ZIMMER, INC. |
| K043560 | PERIARTICULAR LOCKING PLATES AND SCREWS, SERIES 2358 AND 2359 | Jan 21, 2005 | Substantially Equivalent | ZIMMER, INC. |
| K043263 | TRIMED OSTEOTOMY PLATE | Jan 14, 2005 | Substantially Equivalent | TRIMED, INC. |
| K043227 | PERIARTICULAR LOCKING PLATES, 2358 SERIES | Dec 10, 2004 | Substantially Equivalent | ZIMMER, INC. |
| K042766 | ORTHOFIX VOLAR DISTAL RADIAL PLATE | Nov 16, 2004 | Substantially Equivalent | ORTHOFIX, INC. |
| K042695 | NCB PLATING SYSTEM | Oct 29, 2004 | Substantially Equivalent | ZIMMER GMBH |
| K042598 | PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES | Oct 29, 2004 | Substantially Equivalent | ZIMMER, INC. |
| K042355 | SYNTHES (USA) LCP WRIST FUSION PLATES | Oct 27, 2004 | Substantially Equivalent | SYNTHES (USA) |
| K042437 | DORSAL INTRAMEDULLARY PLATE | Oct 08, 2004 | Substantially Equivalent | DEO VOLENTE ORTHOPAEDICS, LLC |
| K042377 | SYNTHES LOW PROFILE RECONSTRUCTION PLATES | Oct 07, 2004 | Substantially Equivalent | SYNTHES (USA) |
| K042205 | BONE FUSION PLATE SYSTEM | Sep 20, 2004 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K042237 | EBI PERIARTICULAR PLATING SYSTEM | Sep 16, 2004 | Substantially Equivalent | EBI, L.P. |
| K041965 | ARTHREX HUMERAL FRACTURE PLATES AND SCREWS | Sep 08, 2004 | Substantially Equivalent | ARTHREX, INC. |
| K041860 | SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG | Sep 08, 2004 | Substantially Equivalent | SYNTHES (USA) |
| K041786 | CALCAMEA PLATE | Sep 08, 2004 | Substantially Equivalent | NEWDEAL S.A. |
| K041601 | SURFIX KNEE OSTEOTOMY SYSTEM | Aug 27, 2004 | Substantially Equivalent | SURFIX TECHNOLOGIES |
| K041461 | KMI DISTAL VOLAR RADIUS PLATE SYSTEM | Aug 16, 2004 | Substantially Equivalent | KINETIKOS MEDICAL, INC. |
| K033918 | EBI LACTOSORB GRAFT CONTAINMENT SYSTEM | Aug 16, 2004 | Substantially Equivalent | EBI, L.P. |
| K040938 | RADIAL NAIL SYSTEM | Jul 01, 2004 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K040907 | ARTHREX SMALL FRAGMENT PLATES AND SCREWS | Jul 01, 2004 | Substantially Equivalent | ARTHREX, INC. |
| K040908 | EBI DISTAL RADIUS PLATING SYSTEM | Jun 25, 2004 | Substantially Equivalent | EBI, L.P. |
| K040850 | TSY SHOULDER PLATE IMPLANT | Jun 24, 2004 | Substantially Equivalent | ORTHOPEDIC SCIENCES, INC |
| K033303 | WAFER SYSTEM | Jun 24, 2004 | Substantially Equivalent | SPINE WAVE, INC. |
| K040777 | LCP RADIAL HEAD PLATING SYSTEM | Jun 18, 2004 | Substantially Equivalent | SYNTHES (USA) |
| K040860 | INTEGRA BONE FIXATION SYSTEM | Jun 17, 2004 | Substantially Equivalent | INTEGRA LIFESCIENCES CORPORATION |
| K040598 | KLS MARTIN HAND PLATING SYSTEM | May 13, 2004 | Substantially Equivalent | KLS-MARTIN L.P. |
| K040588 | SYNTHES (USA) 2.4 MM LCP WRIST PLATE | May 07, 2004 | Substantially Equivalent | SYNTHES (USA) |
| K040593 | PERIARTICULAR LOCKING PLATES AND SCREWS, 2358, 2359 SERIES | Apr 12, 2004 | Substantially Equivalent | ZIMMER, INC. |
| K040112 | TRIMED BEARING PLATE; TRIMED VOLAR BEARING PLATE | Mar 12, 2004 | Substantially Equivalent | TRI-MED, INC. |
| K040022 | STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM | Mar 12, 2004 | Substantially Equivalent | STRYKER LEIBINGER |
| K031961 | INION OTPS BIODEGRADABLE MESH PLATING SYSTEM | Mar 01, 2004 | Substantially Equivalent | INION LTD. |
| K033756 | VOLAR RADIUS PLATE WITH ANGULAR STABILITY | Feb 06, 2004 | Substantially Equivalent | I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
| K030877 | TRIMED RADIAL BULLET | Feb 05, 2004 | Substantially Equivalent | TRI-MED, INC. |
| K033456 | EVOLVE RADIAL PLATE | Jan 28, 2004 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K033669 | SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS) | Dec 10, 2003 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K033519 | CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET | Dec 05, 2003 | Substantially Equivalent | BIOMET, INC. |
| K031493 | GROWTH GUIDANCE PLATE | Nov 20, 2003 | Substantially Equivalent | UNIVERSITY OF UTAH/SCHOOL OF MEDICINE |
| K031666 | ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS | Nov 18, 2003 | Substantially Equivalent | ARTHREX, INC. |
| K032559 | SYNTHES 4.0MM TITANIUM (TI.) LOCKING SCREWS | Oct 22, 2003 | Substantially Equivalent | SYNTHES (USA) |
| K032413 | KLS-MARTIN STERNAL PLATING SYSTEM | Oct 10, 2003 | Substantially Equivalent | KLS-MARTIN L.P. |
| K032187 | ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM | Sep 22, 2003 | Substantially Equivalent | ARTHREX, INC. |
| K032269 | SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES | Sep 17, 2003 | Substantially Equivalent | SYNTHES (USA) |
| K032032 | SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES | Sep 04, 2003 | Substantially Equivalent | SYNTHES (USA) |
| K031677 | SYNTHES (USA) CALVICLE HOOK PLATE | Aug 21, 2003 | Substantially Equivalent | SYNTHES (USA) |
| K031609 | SWISS ORTHOPEDIC SOLUTIONS, INC., SMALL FRAGMENT LOCKING PLATE SYSTEM | Jun 09, 2003 | Substantially Equivalent | SWISS ORTHOPEDIC SOLUTIONS INC |
| K031334 | TEXAS T - PLATE | May 22, 2003 | Substantially Equivalent | BIOMET, INC. |
| K031178 | SYNTHES (USA) 3.5 MM BROAD LCP & 4.5 MM LCP DISTAL HUMERUS PLATES | May 05, 2003 | Substantially Equivalent | SYNTHES (USA) |
| K030310 | SYNTHES STAINLESS STEEL MODULAR HAND SYSTEM | Apr 22, 2003 | Substantially Equivalent | SYNTHES (USA) |
| K030909 | AAP ACROPLATE | Apr 10, 2003 | Substantially Equivalent | AAP IMPLANTATE AG |
| K030881 | AVANTA CARPAL FUSION PLATING SYSTEM | Apr 10, 2003 | Substantially Equivalent | AVANTA ORTHOPAEDICS, INC. |
| K030858 | SYNTHES (USA) LCP PROXIMAL FEMUR PLATE AND SCREWS | Apr 04, 2003 | Substantially Equivalent | SYNTHES (USA) |
| K030198 | HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM | Apr 01, 2003 | Substantially Equivalent | HAND INNOVATIONS, INC. |
| K030597 | SYNTHES 3.5MM TITANIUM LCP PROXIMAL TIBIA PLATES | Mar 20, 2003 | Substantially Equivalent | SYNTHES (USA) |
| K023879 | SMALL TITANIUM WRIST FUSION PLATE | Feb 05, 2003 | Substantially Equivalent | SYNTHES (USA) |
| K023802 | SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM | Jan 28, 2003 | Substantially Equivalent | SYNTHES (USA) |
| K023007 | DISTAL RADIUS FRACTURE REPAIR SYSTEM | Dec 05, 2002 | Substantially Equivalent | HAND INNOVATIONS, INC. |
| K022139 | HIP TOOL IMPLANT | Sep 23, 2002 | Substantially Equivalent | ORTHOPEDIC SCIENCES, INC |
| K022515 | BIOMET CALCANEAL PLATE | Sep 17, 2002 | Substantially Equivalent | BIOMET ORTHOPEDICS, INC. |
| K022324 | NORMED TITANIUM CALCANEUS PLATING WITH LOCKING SCREW SYSTEM | Sep 17, 2002 | Substantially Equivalent | OSTEOMEDICS, INC. |
| K022231 | NORMED DISTAL RADIUS RECONSTRUCTION SYSTEM | Sep 13, 2002 | Substantially Equivalent | OSTEOMEDICS, INC. |
| K022230 | NORMED MINI EXTERNAL FIXATOR SYSTEM | Sep 10, 2002 | Substantially Equivalent | OSTEOMEDICS, INC. |
| K022325 | NORMED TITANIUM OSTEOTOMY PLATING SYSTEM | Sep 09, 2002 | Substantially Equivalent | OSTEOMEDICS, INC. |
| K022323 | NORMED TITANIUM RONDO FIX FUSION PLATES AND SCREW SYSTEM | Sep 09, 2002 | Substantially Equivalent | OSTEOMEDICS, INC. |
| K021626 | HALLU PLATES | Aug 12, 2002 | Substantially Equivalent | NEWDEAL S.A. |
| K022255 | MODOFOCATION TO SYNTHES ANKLE ARTHRODESIS PLATES | Jul 25, 2002 | Substantially Equivalent | SYNTHES (USA) |
| K021458 | SYNTHES IN-SITU BENDER/CUTTER | Jul 24, 2002 | Substantially Equivalent | SYNTHES (USA) |
| K021321 | WRIST FUSION PLATE | Jul 17, 2002 | Substantially Equivalent | ACUMED, INC. |
| K021164 | MACROPORE OS TRAUMA | Jul 01, 2002 | Substantially Equivalent | MACROPORE BIOSURGERY, INC. |
| K020872 | SYNTHES 3.5 MM BROAD LC-DCP PLATES | Jun 12, 2002 | Substantially Equivalent | SYNTHES (USA) |
| K020602 | SYNTHES PILON PLATE | May 20, 2002 | Substantially Equivalent | SYNTHES |
| K020401 | SYNTHES CALCANEAL PLATE | May 08, 2002 | Substantially Equivalent | SYNTHES (USA) |
| K020819 | DISTAL RADIUS PLATING SYSTEM | Apr 22, 2002 | Substantially Equivalent | BIOMET, INC. |
| K020221 | IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET, IQL SMALL FRAGMENT SET, IQL MINI FRAGMENT SET | Apr 02, 2002 | Substantially Equivalent | BIOMET ORTHOPEDICS, INC. |
| K020611 | UNIVERSAL BONE PLATE III SYSTEM (UBP III) | Mar 27, 2002 | Substantially Equivalent | SPINAL CONCEPTS, INC. |
| K014197 | SYNTHES HIGH TIBIAL OSTEOTOMY PLATE | Mar 21, 2002 | Substantially Equivalent | SYNTHES (USA) |
| K014155 | OPENING/CLOSING WEDGE OSTETOMY PLATES | Mar 18, 2002 | Substantially Equivalent | ARTHREX, INC. |
| K013415 | SYNTHES ANKLE ARTHRODESIS PLATE | Jan 11, 2002 | Substantially Equivalent | SYNTHES (USA) |
| K013775 | TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM | Jan 08, 2002 | Substantially Equivalent | STRYKER LEIBINGER |
| K011139 | LORENZ LACTOSORB PANELS AND FASTENERS | Dec 20, 2001 | Substantially Equivalent | BIOMET, INC. |
| K013248 | SYNTHES LCP DISTAL TIBIA PLATES | Dec 19, 2001 | Substantially Equivalent | SYNTHES (USA) |
| K013657 | MODIFICATION TO: BIOMET HUMERAL CABLE PLATES | Dec 03, 2001 | Substantially Equivalent | BIOMET ORTHOPEDICS, INC. |
| K012655 | CONGRUENT BONE PLATE SYSTEM | Nov 07, 2001 | Substantially Equivalent | ACUMED, INC. |
| K012114 | SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM | Sep 28, 2001 | Substantially Equivalent | SYNTHES (USA) |
| K012162 | STRYKER PLATING SYSTEM BASIC FRAGMENT SET | Aug 31, 2001 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K011978 | SYNTHES LCP PROXIMAL TIBIA PLATE | Aug 09, 2001 | Substantially Equivalent | SYNTHES (USA) |
| K011460 | WUJIN #3 TIBIAL BONE PLATE | Aug 07, 2001 | Substantially Equivalent | BIOPRO, INC. |
| K011459 | WUJIN #3 FEMORAL BONE PLATE | Aug 07, 2001 | Substantially Equivalent | BIOPRO, INC. |
| K011354 | HIGH TIBIAL OSTEOTOMY PLATING SYSTEM | Jul 31, 2001 | Substantially Equivalent | DJ ORTHOPEDICS, LLC |
| K011335 | SYNTHS ONE-THIRD TUBULAR DCL PLATE | Jul 27, 2001 | Substantially Equivalent | SYNTHES (USA) |
| K011334 | SYNTHES CURVED RECONSTRUCTION PLATE | Jul 27, 2001 | Substantially Equivalent | SYNTHES (USA) |
| K011118 | NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM | Jul 20, 2001 | Substantially Equivalent | OSTEOMEDICS |
| K011076 | LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW | Jul 16, 2001 | Substantially Equivalent | WALTER LORENZ SURGICAL, INC. |
| K011170 | SYNTHES 2.7 MM LC-DCP, 3.5 MM PROFILE | Jul 05, 2001 | Substantially Equivalent | SYNTHES (USA) |
| K003788 | SYNTHES RESORABLE MESHES AND SHEETS | May 30, 2001 | Substantially Equivalent | SYNTHES (USA) |
| K011237 | LACTOSORB PLATES, MESHES, AND PANELS/SHEETS | May 23, 2001 | Substantially Equivalent | BIOMET, INC. |
| K002775 | DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM | Dec 05, 2000 | Substantially Equivalent | HAND INNOVATIONS, INC. |
| K002184 | COD COMPRESSION OSTEOTOMY DEVICE | Nov 24, 2000 | Substantially Equivalent | WALTER ABENDSCHEIN, M.D. |
| K002486 | PRECIMED TRAUMA SYSTEM | Nov 09, 2000 | Substantially Equivalent | PATRICK BERDOZ |
| K003235 | PE.R.I. II KNEE FRACTURE SYSTEM | Nov 06, 2000 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K002361 | SYNTHES (USA) LOCKING PROXIMAL PLATING (L-PTP) SYSTEM | Oct 31, 2000 | Substantially Equivalent | SYNTHES (USA) |
| K002710 | MODIFICATION TO SYNTHES (USA) TROCHANTER STABILIZATION PLATE (TSB) FOR DHS (LINE EXTENSION) | Sep 29, 2000 | Substantially Equivalent | SYNTHES (USA) |
| K001945 | SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES | Sep 22, 2000 | Substantially Equivalent | SYNTHES (USA) |
| K001941 | SYNTHES MODULAR FOOT SYSTEM | Sep 22, 2000 | Substantially Equivalent | SYNTHES (USA) |
| K984390 | LACTOSORB PANELS AND FASTENERS | Aug 07, 2000 | Substantially Equivalent | BIOMET, INC. |
| K994158 | MACROSORBOS PROTECTIVE SHEET | Jul 24, 2000 | Substantially Equivalent | MACROPORE BIOSURGERY, INC. |
| K001311 | SYNTHES (USA) ORIBITAL MESH PLATES | Jun 20, 2000 | Substantially Equivalent | SYNTHES (USA) |
| K000636 | STRYKER TRAUMA PLATING SYSTEM | May 11, 2000 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K000066 | SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM | Mar 15, 2000 | Substantially Equivalent | SYNTHES (USA) |
| K994061 | LOCON-T DISTAL RADIAL PLATE | Feb 14, 2000 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K993465 | DEPUY ACE CALCANEAL PERI-ARTICULAR PLATE | Jan 11, 2000 | Substantially Equivalent | DEPUY, INC. |
| K992355 | LACTOSORB TRAUMA PLATING SYSTEM | Dec 20, 1999 | Substantially Equivalent | BIOMET, INC. |
| K993106 | SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES) | Dec 09, 1999 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K993510 | MODIFIED BMP TROCHANTERIC PLATES | Nov 16, 1999 | Substantially Equivalent | BIOMET, INC. |
| K992961 | LORENZ SMALL FRAGMENT SYSTEM | Nov 08, 1999 | Substantially Equivalent | WALTER LORENZ SURGICAL, INC. |
| K991873 | KMI WRIST FUSION SYSTEM | Aug 17, 1999 | Substantially Equivalent | KINETIKOS MEDICAL, INC. |
| K991763 | LACTOSORB HAND SYSTEM | Jul 30, 1999 | Substantially Equivalent | BIOMET, INC. |
| K990596 | DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM | Apr 29, 1999 | Substantially Equivalent | AVANTA ORTHOPAEDICS, INC. |
| K990392 | DEPUY ACE SPIDER PLATE | Mar 23, 1999 | Substantially Equivalent | DEPUY ACE MEDICAL CO. |
| K990481 | ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM | Mar 17, 1999 | Substantially Equivalent | BIODYNAMIC TECHNOLOGIES, INC. |
| K990094 | KMI WRIST FUSION SYSTEM | Feb 18, 1999 | Substantially Equivalent | KINETIKOS MEDICAL, INC. |
| K983988 | SYNTEC-TAICHUNG NON-STERILE TITANIUM ALLOY MINI-PLATE | Jan 27, 1999 | Substantially Equivalent | SYNTEC SCIENTIFIC CORP. |
| K983787 | SYNTHES PROXIMAL TIBIA PLATING SYSTEM | Jan 21, 1999 | Substantially Equivalent | SYNTHES (USA) |
| K984458 | DEPUY ACE SPIDER PLATE | Dec 31, 1998 | Substantially Equivalent | DEPUY ACE MEDICAL CO. |
| K983853 | DEPUY ACE TIMAX META PLATE | Dec 22, 1998 | Substantially Equivalent | DEPUY ACE MEDICAL CO. |
| K983967 | PEDIATRIC CANNULATED OSTEOTOMY PLATES | Dec 16, 1998 | Substantially Equivalent | BIOMET, INC. |
| K983881 | COBRA EXTERNAL FIXATOR | Dec 04, 1998 | Substantially Equivalent | ORTHOPAEDIC INNOVATIONS, INC. |
| K983419 | HOFFMANN II MIAMI POST | Nov 25, 1998 | Substantially Equivalent | HOWMEDICA CORP. |
| K982531 | HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM | Oct 16, 1998 | Substantially Equivalent | HOWMEDICA CORP. |
| K982982 | MINI-FIXATOR FOR COLLES FRACTURES | Oct 13, 1998 | Substantially Equivalent | BIOMET, INC. |
| K982732 | SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS) | Oct 08, 1998 | Substantially Equivalent | SYNTHES |
| K982553 | OSTEO COMPRESSION HIP SCREW SYSTEM | Sep 22, 1998 | Substantially Equivalent | OSTEONICS CORP. |
| K982483 | DEPUY MOTECH PEAK FIXATION SYSTEM | Sep 14, 1998 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K982347 | DEPUY ACE TIMAX PILON PLATE | Aug 31, 1998 | Substantially Equivalent | DEPUY ACE MEDICAL CO. |
| K972913 | MACROPORE PROTECTIVE SHEET (PROTEGO SYSTEM) | Jul 30, 1998 | Substantially Equivalent | PACIFIC MATERIALS AND INTERFACES |
| K981775 | DEPUY ACE TIMAX CALCANEAL PERI-ARTICULAR PLATE | Jul 29, 1998 | Substantially Equivalent | DEPUY ACE MEDICAL CO. |
| K981715 | DISTAL RADIUS FRACTURE FIXATION PLATE | Jul 29, 1998 | Substantially Equivalent | AVANTA ORTHOPAEDICS, INC. |
| K981789 | LORENZ PECTUS SUPPORT BAR STABILIZER | Jul 13, 1998 | Substantially Equivalent | WALTER LORENZ SURGICAL, INC. |
| K981283 | ROGACHEFSKY DISTAL RADIUS PLATES | Jun 10, 1998 | Substantially Equivalent | HOWMEDICA, INC. |
| K973812 | ARTHREX PUDDU OSTEOTOMY SYSTEM | Jun 10, 1998 | Substantially Equivalent | ARTHREX, INC. |
| K980368 | DEPUY MOTECH PEAK 3MM FIXATION ROD SYSTEM | Apr 14, 1998 | Substantially Equivalent | DEPUY, INC. |
| K974908 | SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATES | Mar 18, 1998 | Substantially Equivalent | SYNTHES (USA) |
| K974603 | PLAQUAGRAFE, AGRAFE P4V | Mar 10, 1998 | Substantially Equivalent | ATLAS TECHNOLOGY |
| K974289 | EPI-UNION PLATING SYSTEM | Feb 12, 1998 | Substantially Equivalent for Some Indications | HOWMEDICA, INC. |
| K974309 | LACTOSORB PANELS | Jan 30, 1998 | Substantially Equivalent | BIOMET, INC. |
| K974030 | CARPAL ENGAGING WRIST FUSION PLATE | Jan 21, 1998 | Substantially Equivalent | TERRAY CORP. |
| K974017 | TIMESH SYSTEM | Jan 16, 1998 | Substantially Equivalent | SOFAMOR DANEK USA,INC. |
| K973982 | ORBITAL RECONSTRUCTION PLATES | Jan 12, 1998 | Substantially Equivalent | HOWMEDICA, INC. |
| K973438 | OSTEO BOS SYSTEM PRODUCT LINE EXTENSION | Dec 09, 1997 | Substantially Equivalent | OSTEONICS CORP. |
| K972219 | ORTHOPEDIC PLATE SYSTEM | Nov 20, 1997 | Substantially Equivalent | FERGUSON MEDICAL |
| K973204 | OSTEO BOS SYSTEM IN STAINLESS STEEL | Sep 25, 1997 | Substantially Equivalent | OSTEONICS CORP. |
| K972479 | ALTA PLATING SYSTEM | Sep 11, 1997 | Substantially Equivalent | HOWMEDICA CORP. |
| K972323 | OSTEO BOS SYSTEM | Sep 10, 1997 | Substantially Equivalent | OSTEONICS CORP. |
| K972223 | BONE PLATE WITH CABLES | Sep 10, 1997 | Substantially Equivalent | PIONEER SURGICAL TECHNOLOGY |
| K972196 | OSTEO ANATOMICAL BONE PLATES | Aug 25, 1997 | Substantially Equivalent | OSTEONICS CORP. |
| K971870 | LACTOSORB TRAUMA PLATING SYSTEM | Aug 19, 1997 | Substantially Equivalent | BIOMET, INC. |
| K972420 | LORENZ PECTUS SUPPORT BAR | Aug 11, 1997 | Substantially Equivalent | WALTER LORENZ SURGICAL, INC. |
| K961719 | EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES | Jul 17, 1997 | Substantially Equivalent | HOWMEDICA LEIBINGER, INC. |
| K971321 | OSTEO COMPRESSION CONDYLE SCREW SYSTEM | Jul 09, 1997 | Substantially Equivalent | OSTEONICS CORP. |
| K970258 | FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHSIS OF UNSTABLE FEMORAL NECK FRACTURES | May 22, 1997 | Substantially Equivalent | FERGUSON MEDICAL |
| K971297 | CENTRE-DRIVE DRILL-FREE SCREW | May 08, 1997 | Substantially Equivalent | KLS-MARTIN L.P. |
| K970503 | DEPUY ACE TROCHANTERIC SIDE PLATE | Apr 30, 1997 | Substantially Equivalent | DEPUY ACE MEDICAL CO. |
| K963325 | SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM | Mar 25, 1997 | Substantially Equivalent | SYNTHES (USA) |
| K963700 | METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM | Feb 12, 1997 | Substantially Equivalent | METAGEN, L.L.C. |
| K963741 | LEIBINGER LUHR SMALL CRANIOMAXILLOFACIAL BONE SCREWS | Feb 06, 1997 | Substantially Equivalent | HOWMEDICA LEIBINGER, INC. |
| K961498 | RESCH ARTHROSCOPIC AND PERCUTANEOUS SCREW FIXATION SYSTEM (A.S.F.) | Feb 06, 1997 | Substantially Equivalent | HOWMEDICA, INC. |
| K964362 | KINAMED PROFIX SYSTEM | Jan 16, 1997 | Substantially Equivalent | KINAMED, INC. |
| K962894 | SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM | Dec 17, 1996 | Substantially Equivalent | SYNTHES (USA) |
| K963798 | SYNTHES TITANIUM ALLOY VOLAR DISTAL RADIUS PLATE (TI ALLOY VDRP) SYSTEM | Nov 27, 1996 | Substantially Equivalent | SYNTHES (USA) |
| K962616 | SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEM | Sep 03, 1996 | Substantially Equivalent for Some Indications | SYNTHES (USA) |
| K961497 | PROFYLE TITANIUM HAND AND SMALL FRAGMENT SYSTEM | Jun 28, 1996 | Substantially Equivalent | HOWMEDICA, INC. |
| K961496 | R.R.P.S. RADIUS RECONSTRUTION PLATING SYSTEM | Jun 28, 1996 | Substantially Equivalent | HOWMEDICA, INC. |
| K942032 | PLAMP, PLAMP PLATE, PLAMP WITH HOOK | Jun 13, 1996 | Substantially Equivalent for Some Indications | HOSPITAL FOR SPECIAL SURGERY |
| K961485 | FOREFOOT RECONSTRUCTION SYSTEM | Jun 01, 1996 | Substantially Equivalent | HOWMEDICA CORP. |
| K960988 | LACTOSORB TRAUMA PLATING SYSTEM | Apr 10, 1996 | Substantially Equivalent for Some Indications | POLY-MEDICS,INC. |
| K955472 | ACE HUMERUS & RADIUS PLATES | Apr 01, 1996 | Substantially Equivalent | ACE MEDICAL CO. |
| K954963 | SCHUHLI IMPLANT SYSTEM | Mar 22, 1996 | Substantially Equivalent | SYNTHES (USA) |
| K953644 | VOLAR DISTAL RADIUS PLATE | Mar 08, 1996 | Substantially Equivalent | SYNTHES (USA) |
| K955729 | LACTOSORB TRAUMA PLATING SYSTEM | Feb 14, 1996 | Substantially Equivalent for Some Indications | POLY-MEDICS,INC. |
| K952766 | RAYHACK OSTEOTOMY SYSTEM (MODIFICATION) | Dec 13, 1995 | Substantially Equivalent for Some Indications | CREATIVE MEDICAL DESIGNS, INC. |
| K953714 | ZIMMER RECONSTRUCTION SYSTEM SYMPHYSEAL BONE PLATE | Nov 20, 1995 | Substantially Equivalent for Some Indications | ZIMMER, INC. |
| K943986 | LINK ENDO MODEL REVISION CUP | Jul 05, 1995 | Substantially Equivalent | TURNKEY INTERGRATION USA, INC. |
| K932352 | ORTHOPEDIC BONE PLATE | Jul 05, 1995 | Substantially Equivalent | OSTEOMED CORP. |
| K951415 | LUHR PAN FIXATION SYSTEM CONDENSED STRAIGHT PLATE, Y PLATES AND 1.5MM BONE SCREW | Jun 22, 1995 | Substantially Equivalent | HOWMEDICA CORP. |
| K945139 | LUHR TITANIUM PAN FIXATION SYSTEM | Jun 12, 1995 | Substantially Equivalent | HOWMEDICA CORP. |
| K945137 | LUHR TITANIUM ALLOY PAN FIXATION SYSTEM | Jun 12, 1995 | Substantially Equivalent | HOWMEDICA CORP. |
| K946165 | CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEM | May 23, 1995 | Substantially Equivalent | ELEKTA INSTRUMENTS, INC. |
| K944856 | ORTHOMET ACETABULAR ROOF REINFORCEMENT RING | May 16, 1995 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K950618 | ACE SUPRACONDYLAR PLATE | May 10, 1995 | Substantially Equivalent | ACE MEDICAL CO. |
| K942359 | BONE PLATE SYSTEM | Apr 13, 1995 | Substantially Equivalent | ACUMED, INC. |
| K950115 | LUHR(R) TITANIUM BURR HOLE COVERS | Apr 10, 1995 | Substantially Equivalent | HOWMEDICA, INC. |
| K950105 | LUHR(R) TITANIUM ALLOY BURR HOLE COVERS | Apr 10, 1995 | Substantially Equivalent | HOWMEDICA CORP. |
| K943853 | DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM | Jan 20, 1995 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K936233 | PELVIC RADIUS PLATE | Aug 01, 1994 | Substantially Equivalent | SMITH & NEPHEW RICHARDS, INC. |
| K930480 | VARIABLE ANGULAR HOLD BONE PLATE SYSTEM | Jun 15, 1994 | Substantially Equivalent | SMITH & NEPHEW RICHARDS, INC. |
| K931690 | SPOON PLATE | Jun 07, 1994 | Substantially Equivalent for Some Indications | ONYX MEDICAL CORP. |
| K934614 | MINI FRAGMENT PLATE | May 04, 1994 | Substantially Equivalent for Some Indications | ONYX MEDICAL CORP. |
| K931692 | T-PLATE | May 04, 1994 | Substantially Equivalent for Some Indications | ONYX MEDICAL CORP. |
| K931684 | EPIPHYSIS PLATE | May 04, 1994 | Substantially Equivalent for Some Indications | ONYX MEDICAL CORP. |
| K931694 | 1/4 TUBULAR PLATE | Apr 25, 1994 | Substantially Equivalent for Some Indications | ONYX MEDICAL CORP. |
| K931693 | 1/3 TUBULAR PLATE | Apr 25, 1994 | Substantially Equivalent for Some Indications | ONYX MEDICAL CORP. |
| K931691 | STRAIGHT MINI-PLATE | Apr 25, 1994 | Substantially Equivalent for Some Indications | ONYX MEDICAL CORP. |
| K931689 | SMALL STRAIGHT PLATE | Apr 25, 1994 | Substantially Equivalent for Some Indications | ONYX MEDICAL CORP. |
| K931688 | SEMI-TUBULAR PLATE | Apr 25, 1994 | Substantially Equivalent for Some Indications | ONYX MEDICAL CORP. |
| K931687 | MULTIPLE FRAGMENT PLATE | Apr 25, 1994 | Substantially Equivalent for Some Indications | ONYX MEDICAL CORP. |
| K931685 | FOREARM SELF COMPRESSION PLATE | Apr 25, 1994 | Substantially Equivalent for Some Indications | ONYX MEDICAL CORP. |
| K931683 | CLOVERLEAF PLATE | Apr 25, 1994 | Substantially Equivalent for Some Indications | ONYX MEDICAL CORP. |
| K931679 | BUTTRESS PLATE | Apr 25, 1994 | Substantially Equivalent for Some Indications | ONYX MEDICAL CORP. |
| K930966 | BAUMER PLATES | Apr 25, 1994 | Substantially Equivalent | BAUMER ORTOPEDIA LTD. |
| K935448 | LUHR MINI BONE SCREW AND Z PLATE | Feb 23, 1994 | Substantially Equivalent for Some Indications | HOWMEDICA CORP. |
| K933112 | ALPHATEC COMPRESSION AND RECONSTRUCTION PLATES | Feb 17, 1994 | Substantially Equivalent | ALPHATEC MFG., INC. |
| K931244 | BONE PLATE | Feb 15, 1994 | Substantially Equivalent | ACUMED, INC. |
| K930592 | ACE UNIVERSAL RECONSTRUCTION PLATE | Jul 26, 1993 | Substantially Equivalent | ACE MEDICAL CO. |
| K925571 | OTI EUROPEAN COMPRESSION SYSTEM | Jul 13, 1993 | Substantially Equivalent | OSTEO-TECHNOLOGY INTL., INC. |
| K925500 | ALPHATEC 130 COMPRESSION HIP SCREW | Apr 14, 1993 | Substantially Equivalent | ALPHATEC MFG., INC. |
| K923861 | LUHR PAN FIXATION SYSTEM | Mar 04, 1993 | Substantially Equivalent | HOWMEDICA CORP. |
| K921338 | ANSPACH MINI-PLATING SYSTEM | Feb 10, 1993 | Substantially Equivalent | THE ANSPACH EFFORT, INC. |
| K924085 | RECONSTRUCTION PLATE SYSTEM | Dec 17, 1992 | Substantially Equivalent for Some Indications | SOFAMOR DANEK MFG., INC. |
| K922525 | DALL MILES BROAD BONE PLATE | Sep 22, 1992 | Substantially Equivalent for Some Indications | HOWMEDICA CORP. |
| K922167 | ALPHATEC COMPRESSION AND RECONSTRUCTION PLATES | Aug 06, 1992 | Substantially Equivalent | ALPHATEC MFG., INC. |
| K920738 | ACE 100 DEGREES TUBULAR PLATE | Jul 27, 1992 | Substantially Equivalent | ACE ORTHOPEDIC MANUFACTURING CO. |
| K921458 | TMP MICROPLATING SYSTEM | Jul 17, 1992 | Substantially Equivalent | TECHMEDICA, INC. |
| K921622 | ALPHATEC COMPRESSION HIP SCREW SYSTEM | Jul 02, 1992 | Substantially Equivalent | ALPHATEC MFG., INC. |
| K914998 | MICROAIRE(R) FACIAL BONE PLATING SYSTEM | Jun 02, 1992 | Substantially Equivalent | MICRO SURGICAL INSTRUMENTS CORP. |
| K914804 | RADIUS OSTEOTOMY PLATES | Apr 29, 1992 | Substantially Equivalent for Some Indications | LINK AMERICA, INC. |
| K914803 | SCHWABE RADIUS PLATES | Apr 28, 1992 | Substantially Equivalent | LINK AMERICA, INC. |
| K915315 | AAP BONE PLATE | Feb 20, 1992 | Substantially Equivalent | AAP INTERNATIONAL, LTD. |
| K915818 | SYNTHES(R) TITANIUM SMALL RECONSTRUCTION PLATE | Jan 17, 1992 | Substantially Equivalent | SYNTHES (USA) |
| K913355 | LUHR PAN FIXATION SYSTEM | Dec 02, 1991 | Substantially Equivalent | HOWMEDICA CORP. |
| K913271 | OSTEO BONE PLATED | Oct 17, 1991 | Substantially Equivalent | FRED C. BRYSON |
| K913930 | FIXATION DEVICES AND BONE PLATE | Oct 04, 1991 | Substantially Equivalent | JOHN M. RAYHACK |
| K912932 | SYNTHES MAXILLOFACIAL TITANIUM MICRO SET | Sep 25, 1991 | Substantially Equivalent | SYNTHES (USA) |
| K912936 | MAY HUMERUS PLATES | Sep 06, 1991 | Substantially Equivalent | TURNKEY INTERGRATION USA, INC. |
| K913289 | MASTERPIECES(TM)/MICRO/MINI SYSTEMS | Sep 05, 1991 | Substantially Equivalent | STORZ INSTRUMENT CO. |
| K910482 | ALTA CHANNEL PLATE CONNECTOR | Jul 30, 1991 | Substantially Equivalent | HOWMEDICA CORP. |
| K910957 | MASTERPIECES MICRO SYSTEM | Jul 26, 1991 | Substantially Equivalent | STORZ INSTRUMENT CO. |
| K905024 | TMP MANDIBULAR COMPRESSION SYSTEM | Jun 24, 1991 | Substantially Equivalent for Some Indications | TECHMEDICA, INC. |
| K910175 | FIXATION DEVICES AND BONE PLATE | Jun 21, 1991 | Substantially Equivalent for Some Indications | MICRO SURGICAL INSTRUMENTS CORP. |
| K905774 | THACKRAY TITANIUM MINI-PLATING SYSTEM | Jun 13, 1991 | Substantially Equivalent | DEPUY, INC. |
| K905595 | ACE RECONSTRUCTIVE PLATE | Mar 14, 1991 | Substantially Equivalent | ACE MEDICAL CO. |
| K903697 | HAWAIIAN SUPRACONDYLAR PLATE | Jan 15, 1991 | Substantially Equivalent | MEDPAC |
| K905355 | BROAD SELF-COMPRESSING PLATE | Jan 04, 1991 | Substantially Equivalent for Some Indications | O'TEC CORP. |
| K895243 | BARNES FEMORAL LENGTHENING DEVICE | Aug 10, 1990 | Substantially Equivalent | PIEDMONT SPORTS MEDICINE & ORTHOPAEDIC CLINIC |
| K903252 | BROAD SELF-COMPRESSING PLATE | Aug 09, 1990 | Substantially Equivalent for Some Indications | ONYX MEDICAL CORP. |
| K893201 | BONE PLATE | Apr 04, 1990 | Substantially Equivalent | KARLIN TECHNOLOGY, INC. |
| K892228 | INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM | Oct 06, 1989 | Substantially Equivalent | INTERMEDICS ORTHOPEDICS |
| K890939 | DUPONT DISTAL HUMERAL NAIL | May 22, 1989 | Substantially Equivalent | HOWMEDICA CORP. |
| K890641 | ACUFEX CANNULATED SCREWS, WASHERS, BONE PLATES | Feb 27, 1989 | Substantially Equivalent | ACUFEX MICROSURGICAL, INC. |
| K885250 | ALTA TIBIAL/UPPER EXTREMITY METAPHYSEAL PLATE SYS | Feb 13, 1989 | Substantially Equivalent | HOWMEDICA CORP. |
| K882454 | LUHR MICRO SYSTEM | Aug 19, 1988 | Substantially Equivalent | HOWMEDICA CORP. |
| K875086 | ORTHOMET BONE PLATES | Jan 14, 1988 | Substantially Equivalent | ORTHOMET, INC. |
| K873005 | TECHMEDICA HEAVYD GAUGE TITANIUM MESH SHEET/STRIPS | Sep 01, 1987 | Substantially Equivalent | TECHMEDICA, INC. |
| K870082 | BONE PLATE | May 06, 1987 | Substantially Equivalent | TERRAY MANUFACTURING, INC. |
| K870388 | HOFFMANN LEG LENGTHENING PLATE SYSTEM | Apr 03, 1987 | Substantially Equivalent | HOWMEDICA CORP. |
| K864924 | KIRSCHNER (R) SMALL FRAGMENT FIXATION SYSTEM | Mar 20, 1987 | Substantially Equivalent | KIRSCHNER MEDICAL CORP. |
| K862254 | WARSAW ORTHOPEDIC BONE PLATE | Jul 08, 1986 | Substantially Equivalent | WARSAW ORTHOPEDIC, INC. |
| K860600 | SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION | Mar 13, 1986 | Substantially Equivalent | 3M COMPANY |
| K860591 | ACE MULTIPLE PIN PLATE | Mar 10, 1986 | Substantially Equivalent | BUCKMAN CO., INC. |
| K854825 | LINK SMALL BONE PLATES | Jan 21, 1986 | Substantially Equivalent | LINK AMERICA, INC. |
| K853709 | A RANGE OF INSTRUMENTS & PLATES FOR MANDIBULAR COM | Nov 15, 1985 | Substantially Equivalent | DOWNS SURGICAL LTD. |
| K850025 | ORTHOPEDIC IMPLANT PLATES | May 20, 1985 | Substantially Equivalent | KIRKSTIL CORP., INC. |
| K850444 | MEC BUTRESS PLATE | Apr 19, 1985 | Substantially Equivalent | PFIZER, INC. |
| K850442 | MEC BROAD BONE PLATE | Apr 19, 1985 | Substantially Equivalent | PFIZER, INC. |
| K850401 | LETOURNEL ACETABULAR PLATE | Apr 19, 1985 | Substantially Equivalent | PFIZER, INC. |
| K843370 | IMSI/METRIPOND GRIPPER PLATE | Jan 23, 1985 | Substantially Equivalent | INTL. MANAGEMENT SERVICES, INC. |
| K840954 | DYNAMIC CONDYLAR SCREW OR D.C.S. | May 11, 1984 | Substantially Equivalent | SYNTHES (USA) |
| K833865 | ACE BROOKER BONE PLATING SYSTEM | Dec 12, 1983 | Substantially Equivalent | BUCKMAN CO., INC. |
| K811244 | CRYOPHTHALMIC UNIT | Jun 23, 1981 | Substantially Equivalent | KEELER INSTRUMENTS, INC. |
| K810061 | CURVED SHERMAN BONE PLATE | Jan 23, 1981 | Substantially Equivalent | HOWMEDICA CORP. |
| K803176 | INTEROOM(POWERED OPHTHALMIC TABLE) | Jan 09, 1981 | Substantially Equivalent | JOCEVEST INTEROOM, INC. |
| K801603 | POLYETHYLENE FILLED BONE PLATE | Oct 03, 1980 | Substantially Equivalent | ZIMMER, INC. |
| K800806 | I.C.S. MINI & SMALL FRAGMENT SET | Apr 21, 1980 | Substantially Equivalent | HOWMEDICA CORP. |
| K800502 | ADDITIONAL COMPONENTS KRONNER COMPRES | Apr 02, 1980 | Substantially Equivalent | RICHARD F. KRONNER, M.D. |
| K782123 | MULTIPLICITY OF PRODUCTS | Jan 10, 1979 | Substantially Equivalent | DEPUY, INC. |
| K770128 | B.G. COMPRESSION SYSTEM | Jan 26, 1977 | Substantially Equivalent | HOWMEDICA CORP. |
| K761150 | GALLENAUGH BONE PLATES | Dec 16, 1976 | Substantially Equivalent | ORTHOPEDIC EQUIPMENT CO., INC. |
FEI Numbers
This FDA classification entry is associated with 505 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 505 registration numbers. Click on an entry to view related FDA registrations.