Appliance, Fixation, Spinal Intervertebral Body
The Spinal Intervertebral Body Fixation Appliance is an orthopedic implant placed between or around vertebral bodies to restore disc height, provide structural support, or promote spinal fusion, used in the surgical management of degenerative disc disease and spinal instability. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KWQ, regulated under 21 CFR 888.3060, in the Orthopedic medical specialty. This device is an implant.
Basic Information
- Product Code
- KWQ
- Device Class
- FDA class 2
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 656 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251436 | Resolve Anterior Cervical Plate System | Jul 11, 2025 | Substantially Equivalent | Pioneer Surgical Technology, Inc |
| K250446 | Frida Anterior Cervical Plate System | May 23, 2025 | Substantially Equivalent | SpineUp, Inc. |
| K250602 | X-PAC® N-GAGE Lumbar Plate System | May 20, 2025 | Substantially Equivalent | Expanding Innovations, Inc |
| K250486 | Skyway Anterior Cervical Plate System | Apr 10, 2025 | Substantially Equivalent | Kyocera Medical Technologies, Inc. (KMTI) |
| K243904 | Elegance® Anterior Cervical plate | Jan 14, 2025 | Substantially Equivalent | CLARIANCE |
| K243369 | Cervical Plating System | Dec 11, 2024 | Substantially Equivalent | Life Spine, Inc. |
| K242361 | OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI | Nov 07, 2024 | Substantially Equivalent | Stryker Spine |
| K243015 | Skyway Anterior Cervical Plate System | Nov 05, 2024 | Substantially Equivalent | Kyocera Medical Technologies, Inc. |
| K231251 | FlexWing Anterior Cervical Plate System | Jul 24, 2024 | Substantially Equivalent | Jeil Medical Corporation |
| K240592 | Wolff's Law Anterior Cervical Plate System | May 24, 2024 | Substantially Equivalent | Spinal Simplicity LLC |
| K241175 | MiRus MoRe Lumbar Plating System | May 17, 2024 | Substantially Equivalent | MiRus, LLC |
| K240935 | ARENAL Anterior Cervical Plate System | May 17, 2024 | Substantially Equivalent | EffortMed, LLC |
| K233215 | icotec Anterior Cervical Plate System | May 17, 2024 | Substantially Equivalent | Icotec AG |
| K240484 | MSFX Mikron Cervical Anterior Plate System | Apr 17, 2024 | Substantially Equivalent | Mikron Makina Sanayi ve Ticaret Ltd. Sti. |
| K232256 | Alcantara Thoracolumbar Plate System | Apr 16, 2024 | Substantially Equivalent | Camber Spine Technologies, LLC |
| K240423 | TDM Anterior Cervical Plate System | Apr 08, 2024 | Substantially Equivalent | TDM Co., Ltd. |
| K240690 | STRUXXURE® MCS Anterior Cervical Plate System | Mar 22, 2024 | Substantially Equivalent | Nexxt Spine |
| K240515 | uNion® MAX Cervical Plate System | Mar 18, 2024 | Substantially Equivalent | Ulrich Medical USA, Inc. |
| K233360 | Curiteva Thoracolumbar Plate System | Feb 29, 2024 | Substantially Equivalent | Curiteva, Inc. |
| K233640 | Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System | Feb 22, 2024 | Substantially Equivalent | Alphatec Spine Inc. |
| K231715 | MONDRIAN Anterior Lumbar Plate System | Jan 26, 2024 | Substantially Equivalent | CTL Medical Corporation |
| K233735 | ADIRA Lateral Plate System | Jan 25, 2024 | Substantially Equivalent | Globus Medical Inc |
| K232318 | VICTORY Lumbar Plate System | Oct 31, 2023 | Substantially Equivalent | Globus Medical, Inc |
| K231766 | Skyway Anterior Cervical Plate System | Sep 12, 2023 | Substantially Equivalent | Kyocera Medical Technologies, Inc. (KMTI) |
| K231593 | Sapphire X3 Anterior Cervical Plate System | Aug 02, 2023 | Substantially Equivalent | Spinal Elements, Inc |
| K231839 | CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System | Jul 19, 2023 | Substantially Equivalent | L & K Biomed Co., Ltd. |
| K231460 | FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM & BALTEUM-ONE Lumbar Plate System, and Osprey Anterior Cervical Plate System | Jul 16, 2023 | Substantially Equivalent | K&J Consulting Corp. |
| K230993 | CODA Anterior Cervical Plate System | Jun 20, 2023 | Substantially Equivalent | Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech |
| K231090 | Zevo Anterior Cervical Plate System | Jun 15, 2023 | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. |
| K231145 | Axis Anterior Cervical Plate System | Jun 13, 2023 | Substantially Equivalent | Southern Medical (Pty) Ltd |
| K230721 | ATEC Lateral Plate System | May 09, 2023 | Substantially Equivalent | Alphatec Spine, Inc. |
| K230424 | Omnia Medical Coupler-A Anterior Lumbar Plate System; Omnia Medical Coupler-L Lateral Lumbar Plate System | Apr 12, 2023 | Substantially Equivalent | Omnia Medical, LLC |
| K223753 | Cervical Plate System | Mar 14, 2023 | Substantially Equivalent | Double Medical Technology Inc. |
| K223321 | Omnia Medical Coupler-C Anterior Cervical Plate | Mar 13, 2023 | Substantially Equivalent | Omnia Medical, LLC |
| K230301 | Athena III Cervical Plate System | Mar 07, 2023 | Substantially Equivalent | Medyssey USA, Inc. |
| K221053 | Magnes-C Anterior Cervical Plate System | Mar 01, 2023 | Substantially Equivalent | Fellowship of Orthopaedic Researchers, Inc. |
| K223627 | PreView-III Anterior Cervical Plate System | Feb 02, 2023 | Substantially Equivalent | Nexus Spine, LLC |
| K223719 | Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System | Jan 11, 2023 | Substantially Equivalent | Aegis Spine, Inc. |
| K220843 | OAKTREE Anterior Lumbar Plate and Screw System | Dec 07, 2022 | Substantially Equivalent | Oak Tree Engineering, LLC. |
| K222493 | CODA Anterior Cervical Plate System | Nov 18, 2022 | Substantially Equivalent | Pioneer Surgical Technology, Inc., |
| K222628 | Life Spine ALIF Buttress Plate System | Nov 16, 2022 | Substantially Equivalent | Life Spine, Inc. |
| K220334 | MONET Anterior Cervical Plate System | Nov 09, 2022 | Substantially Equivalent | CTL Medical Corporation |
| K221728 | Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran Anterior Cervical Plating (ACP) System, Reflex Hybrid ACP System, UniVise Spinous Process Fixation Plate | Oct 19, 2022 | Substantially Equivalent | Stryker Corporation |
| K222572 | FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM & BALTEUM-ONE Lumbar Plate System | Oct 18, 2022 | Substantially Equivalent | Dio Medical Corporation |
| K220441 | CYGNUS MoRe Anterior Cervical Plate System | Sep 16, 2022 | Substantially Equivalent | MiRus, LLC |
| K221572 | VyPlate Anterior Cervical Plate System | Jul 26, 2022 | Substantially Equivalent | Vy Spine, LLC |
| K211718 | Venus Cervical Plate System | Jun 28, 2022 | Substantially Equivalent | ArtFx Medical LLC |
| K212527 | Cervical Spine Truss System Plating Solution (CSTS-PS) | May 17, 2022 | Substantially Equivalent | 4WEB Medical, Inc. |
| K220182 | Aggeris-C | Mar 30, 2022 | Substantially Equivalent | Clariance |
| K213820 | BALTEUM - ONE Lumbar Plate System | Mar 25, 2022 | Substantially Equivalent | Huvexel Co., Ltd |
| K220275 | EMERGE Anterior Cervical Plate System | Mar 18, 2022 | Substantially Equivalent | Evolution Spine |
| K220324 | AccuFit Lateral 2-Hole Plate | Mar 16, 2022 | Substantially Equivalent | Precision Spine, Inc. |
| K220379 | IMPEACE and IMPEACE-Uni Anterior Cervical Plate System | Mar 03, 2022 | Substantially Equivalent | Medynus Inc. |
| K220147 | Aspiron S ACP System | Feb 16, 2022 | Substantially Equivalent | U&I Corporation |
| K211712 | 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System | Feb 11, 2022 | Substantially Equivalent | Orthofix US LLC |
| K213901 | Cyclops Anterior Cervical Plate System | Jan 07, 2022 | Substantially Equivalent | DeGen Medical |
| K213219 | Vy Spine VyWasher Buttress System | Dec 23, 2021 | Substantially Equivalent | Vy Spine, LLC |
| K213456 | Xenco Medical Multilevel CerviKit | Dec 21, 2021 | Substantially Equivalent | Xenco Medical, LLC |
| K213443 | Insignia Anterior Cervical Plate System | Dec 15, 2021 | Substantially Equivalent | Alphatec Spine, Inc. |
| K212937 | Dakota ALIF Plate System | Nov 04, 2021 | Substantially Equivalent | Precision Spine, Inc. |
| K212446 | NuVasive Anterior Cervical Plate Systems | Nov 03, 2021 | Substantially Equivalent | NuVasive, Incorporated |
| K210424 | Quantum Anterior Cervical Plate | Oct 22, 2021 | Substantially Equivalent | Nvision Biomedical Technologies, Inc. |
| K212405 | EMERGE Anterior Cervical Plate System | Sep 30, 2021 | Substantially Equivalent | Evolution Spine |
| K212139 | Admiral ACP System | Sep 01, 2021 | Substantially Equivalent | SeaSpine Orthopedics Corporation |
| K211903 | Shoreline Threaded TruProfile® Plate | Aug 30, 2021 | Substantially Equivalent | SeaSpine Orthopedics Corporation |
| K211205 | Prase-C Anterior Cervical Plate System | Aug 12, 2021 | Substantially Equivalent | GBS Commonwealth Co., Ltd. |
| K211932 | Fixxsure Anterior Lumbar Plate and Screw System | Jul 27, 2021 | Substantially Equivalent | Oak Tree Engineering, LLC. |
| K211408 | CervAlign® Anterior Cervical Plate System | Jun 23, 2021 | Substantially Equivalent | Pioneer Surgical Technology, Inc. |
| K210182 | PANAMA Anterior Cervical Plate (ACP) System | Apr 07, 2021 | Substantially Equivalent | FloSpine |
| K210325 | APOLLO Anterior Cervical Plate (ACP) System | Mar 23, 2021 | Substantially Equivalent | Aurora Spine, Inc. |
| K210286 | Cure 2.0 Anterior Cervical Plate (ACP) System | Mar 18, 2021 | Substantially Equivalent | Meditech Spine, LLC |
| K203065 | Lumbar Spine Truss System Plating Solution (LSTS-PS) | Mar 10, 2021 | Substantially Equivalent | 4Web, Inc. |
| K202878 | Prase-AP Anterior Cervical Plate System | Jan 29, 2021 | Substantially Equivalent | GBS Commonwealth Co., Ltd. |
| K203253 | NuVasive ACP System | Dec 03, 2020 | Substantially Equivalent | NuVasive, Incorporated |
| K202972 | Anterior Cervical Plate System | Nov 24, 2020 | Substantially Equivalent | Nutech Spine and Biologics |
| K203154 | KASILOF Cervical Plate System | Nov 05, 2020 | Substantially Equivalent | Kahtnu Surgical, Inc |
| K202624 | Z-Span Plate System | Nov 04, 2020 | Substantially Equivalent | Zavation Medical Products LLC |
| K201587 | icotec Anterior Cervical Plate System | Oct 15, 2020 | Substantially Equivalent | Icotec AG |
| K202309 | Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System | Oct 08, 2020 | Substantially Equivalent | Zimmer Biomet Spine, Inc. |
| K202192 | STRUXXURE®-L and STRUXXURE®-A Plate System | Sep 17, 2020 | Substantially Equivalent | Nexxt Spine LLC |
| K202227 | Artus cervical plate system | Sep 14, 2020 | Substantially Equivalent | Ulrich GmbH & Co. KG |
| K202064 | Admiral ACP System | Aug 26, 2020 | Substantially Equivalent | SeaSpine Orthopedics Corporation |
| K201979 | Cervical Plate System | Aug 25, 2020 | Substantially Equivalent | Eminent Spine, LLC |
| K201521 | Medina Anterior Cervical Plate System | Aug 06, 2020 | Substantially Equivalent | Alliance Partners, LLC |
| K201079 | Aurora® Anterior Lumbar Plate Sytstem | Aug 05, 2020 | Substantially Equivalent | Prism Surgical Design Pty Ltd. |
| K192481 | AccelFix Lumbar Plate System | Jul 28, 2020 | Substantially Equivalent | L&K Biomed Co., Ltd. |
| K200927 | Transept Cervical Plate System | Jul 24, 2020 | Substantially Equivalent | Neurostructures, Inc. |
| K201029 | Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System | Jun 17, 2020 | Substantially Equivalent | Spinal Elements, Inc. |
| K200883 | CarboClear® Cervical Plate System | Jun 04, 2020 | Substantially Equivalent | Carbofix Orthopedics Ltd. |
| K200885 | Meridian Anterior Plate System, Regatta Lateral Plate System | May 28, 2020 | Substantially Equivalent | SeaSpine Orthopedics Corporation |
| K200995 | Insignia Anterior Cervical Plate System | May 21, 2020 | Substantially Equivalent | Alphatec Spine, Inc. |
| K200956 | NuVasive Thoracolumbar Plates | May 21, 2020 | Substantially Equivalent | NuVasive, Incorporated |
| K201078 | NuVasive® ACP System | May 20, 2020 | Substantially Equivalent | NuVasive, Incorporated |
| K201136 | Cure Lumbar Plate System | May 12, 2020 | Substantially Equivalent | Meditech Spine, LLC |
| K200846 | Balteum Lumbar Plate System | May 05, 2020 | Substantially Equivalent | Huvexel Co., Ltd |
| K200523 | Biolign® Roto-Loc Cervical Plate System | Apr 30, 2020 | Substantially Equivalent | Elite Surgical Supplies (PTY) LTD |
| K193494 | Origin Anterior Cervical Plate System | Apr 06, 2020 | Substantially Equivalent | Orthopaedic & Spine Development |
| K200224 | SEA-LINK Anterior Cervical Plate System | Mar 24, 2020 | Substantially Equivalent | Indius Medical Technologies Pvt. Ltd. |
| K200170 | SpineNet SSP System | Feb 05, 2020 | Substantially Equivalent | SpineNet LLC |
| K192792 | TranS1 AxiaLIF Plus System | Nov 20, 2019 | Substantially Equivalent | TranS1 |
| K192049 | Oryx Cervical Plate System | Nov 08, 2019 | Substantially Equivalent | Innovasis, Inc. |
| K192494 | NexGen Anterior Cervical Plate System | Oct 29, 2019 | Substantially Equivalent | Precision Spine |
| K192678 | Genesys Spine Binary® Lumbar Plate System | Oct 24, 2019 | Substantially Equivalent | Genesys Spine |
| K192314 | RESONATE Anterior Cervical Plate System | Oct 23, 2019 | Substantially Equivalent | Globus Medical Inc. |
| K191584 | FORTICO Anterior Cervical Fixation System | Oct 22, 2019 | Substantially Equivalent | Camber Spine Technologies LLC |
| K191500 | NuVasive® ACP System | Sep 03, 2019 | Substantially Equivalent | NuVasive, Incorporated |
| K191786 | Cyclops Anterior Cervical Plate System | Aug 30, 2019 | Substantially Equivalent | DeGen Medical INC |
| K192076 | Binary® Anterior Cervical Plate System | Aug 29, 2019 | Substantially Equivalent | Genesys Spine |
| K190016 | Lateral Plate System | Jun 12, 2019 | Substantially Equivalent | CoreLink, LLC |
| K190565 | Cervical Plate | May 31, 2019 | Substantially Equivalent | EiserTech, LLC |
| K183084 | Fuji Cervical Plate System | May 29, 2019 | Substantially Equivalent | Altus Partners, LLC |
| K190584 | CAYMAN LP Plate System | May 15, 2019 | Substantially Equivalent | K2m, Inc. |
| K190170 | MVP Cervical Plate System | May 13, 2019 | Substantially Equivalent | GS Medical Co., Ltd. |
| K190666 | CYGNUS Anterior Cervical Plate System | May 09, 2019 | Substantially Equivalent | MiRus, LLC |
| K190227 | Boomerang Anterior Cervical Plate System | May 01, 2019 | Substantially Equivalent | ChoiceSpine, LP |
| K183056 | ASSURE® Anterior Cervical Plate System | Apr 19, 2019 | Substantially Equivalent | Globus Medical, Inc. |
| K190425 | CastleLoc-P Anterior Cervical Plate System | Mar 21, 2019 | Substantially Equivalent | L&K BIOMED Co., Ltd. |
| K183409 | Athena II Cervical Plate System | Feb 11, 2019 | Substantially Equivalent | Medyssey USA, Inc. |
| K183073 | SMG Anterior Cervical Plate System | Feb 11, 2019 | Substantially Equivalent | Sapphire Medical Group |
| K182885 | Atlantis Anterior Cervical Plate, Divergence Anterior Cervical Fusion System, Premier Anterior Cervical Plate, Venture Anterior Cervical Plate, Zephir Anterior Cervical Plate System and Zevo Anterior Cervical Plate System | Feb 06, 2019 | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. |
| K190053 | SECULOK ACP System | Feb 01, 2019 | Substantially Equivalent | U&i Corporation |
| K183060 | CervAlign Anterior Cervical Plate System | Jan 17, 2019 | Substantially Equivalent | Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) |
| K181190 | Pinehurst Anterior Cervical Plate System | Jan 17, 2019 | Substantially Equivalent | Signature Orthopaedics Pty Ltd. |
| K182489 | 4CIS® Pinehurst Anterior Cervical Plate system | Jan 16, 2019 | Substantially Equivalent | Solco Biomedical Co., Ltd. |
| K183214 | Raven Lumbar Plate System | Jan 03, 2019 | Substantially Equivalent | Choice Spine, LP |
| K180772 | Met One Czar Anterior Cervical Plate System | Dec 17, 2018 | Substantially Equivalent | Met One Technologies |
| K182473 | PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems | Dec 12, 2018 | Substantially Equivalent | K2M Inc. |
| K182418 | V3 Segmental Plating System | Nov 29, 2018 | Substantially Equivalent | Atlas Spine, Inc. |
| K182808 | Aspida® Anterior Lumbar Plating System | Nov 09, 2018 | Substantially Equivalent | Alphatec Spine, Inc. |
| K181846 | ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thoracolumbar Plate System, PLYMOUTH Thoracolumbar Plate System, SP-Fix Spinous Process Fixation Plate, RELIEVE Laminoplasty Fixation System | Nov 06, 2018 | Substantially Equivalent | Globus Medical Inc. |
| K182055 | SECULOK ACP System | Sep 10, 2018 | Substantially Equivalent | U&i Corporation |
| K181543 | Cure OPEL-C Plate System | Aug 31, 2018 | Substantially Equivalent | Meditech Spine, LLC |
| K181549 | Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System) | Aug 03, 2018 | Substantially Equivalent | Curiteva, LLC |
| K181562 | Curiteva Anterior Cervical Plate System | Aug 02, 2018 | Substantially Equivalent | Curiteva, LLC |
| K180022 | Athena Cervical Plate System | Jul 20, 2018 | Substantially Equivalent | Medyssey USA, Inc. |
| K181063 | Kestrel Buttress Plate System | Jul 13, 2018 | Substantially Equivalent | Innovasis, Inc. |
| K181244 | Zavation Cervical Plate System | Jul 10, 2018 | Substantially Equivalent | Zavation Medical Products LLC |
| K180755 | Vail ALIF Buttress Plate System | Jul 06, 2018 | Substantially Equivalent | Evolution Spine, LLC |
| K180166 | Life Spine Lumbar Fixation System (SENTRY) | Jun 22, 2018 | Substantially Equivalent | Life Spine, Inc. |
| K180090 | Cure Lumbar Plate System | Apr 23, 2018 | Substantially Equivalent | Meditech Spine, LLC |
| K173935 | Mediant Anterior Cervical Plating System | Apr 16, 2018 | Substantially Equivalent | Intelligent Implant Systems, LLC |
| K173867 | Axis Anterior Cervical Plate System | Apr 05, 2018 | Substantially Equivalent | Axis Orthopaedics |
| K173885 | Genesys Spine Binary Lumbar Plate System | Apr 03, 2018 | Substantially Equivalent | Genesys Spine |
| K180537 | Zavation Buttress Plate System | Mar 27, 2018 | Substantially Equivalent | Zavation Medical Products LLC |
| K171797 | TRYPTIK2 C-Plate Anterior Cervical Plate System | Feb 26, 2018 | Substantially Equivalent | Spineart |
| K173521 | SeaSpine Cabo ACP (Anterior Cervical Plate) System | Jan 24, 2018 | Substantially Equivalent | SeaSpine Orthopedics Corporation |
| K173306 | EZ Plate | Jan 22, 2018 | Substantially Equivalent | Zavation Medical Products Llc |
| K173375 | Anterior Cervical Plate System | Dec 21, 2017 | Substantially Equivalent | Evolution Spine, LLC |
| K173091 | Boundary Anterior Lumbar Buttress Plate | Dec 06, 2017 | Substantially Equivalent | Nvision Biomedical Technologies, LLC |
| K173099 | Fortis and Hana Anterior Cervical Plate System | Nov 30, 2017 | Substantially Equivalent | Huvexel Co., Ltd |
| K172585 | Liberty Anterior Cervical Plate | Oct 23, 2017 | Substantially Equivalent | Valorus Spine |
| K163366 | Shanghai Sanyou CARMEN Cervical Fusion System | Oct 05, 2017 | Substantially Equivalent | Shanghai Sanyou Medical Co, LTD |
| K172086 | Matira Anterior Cervical System | Sep 22, 2017 | Substantially Equivalent | Kalitec Direct, LLC |
| K172131 | 2 Hole Lateral Plating System | Aug 28, 2017 | Substantially Equivalent | Life Spine Inc. |
| K172104 | Ozark(tm) Cervical Plate System | Aug 23, 2017 | Substantially Equivalent | K2M Inc. |
| K163625 | NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate System | Aug 11, 2017 | Substantially Equivalent | Signature Orthopaedics Pty Ltd. |
| K171439 | EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, UNIPLATE 2 Anterior Cervical Plate System | Jul 20, 2017 | Substantially Equivalent | Medos International SARL |
| K170224 | Spider Cervical Plating System | Jul 06, 2017 | Substantially Equivalent | X-SPINE SYSTEMS, INC. |
| K163104 | Terrace Anterior Cervical Plate System | Jun 21, 2017 | Substantially Equivalent | CoreLink, LLC |
| K171538 | Cure Lumbar Plate System | Jun 16, 2017 | Substantially Equivalent | Meditech Spine, LLC |
| K171112 | Trifore(tm) Cervical Plating System | Jun 08, 2017 | Substantially Equivalent | NeuroStructures, Inc. |
| K170342 | Ocata Anterior Cervical System | May 09, 2017 | Substantially Equivalent | Kalitec Direct, LLC |
| K170530 | Butrex Lumbar Buttress Plating System | Mar 22, 2017 | Substantially Equivalent | X-Spine Systems, Inc. |
| K162824 | Z-Span Plate System | Feb 17, 2017 | Substantially Equivalent | Zavation, LLC |
| K163602 | Kepler I Cervical Plate System | Feb 16, 2017 | Substantially Equivalent | Orbbo Surgical, LLC. |
| K163061 | Altus Spine Cervical Plate System | Feb 06, 2017 | Substantially Equivalent | Altus Partners, LLC |
| K161641 | LOSPA IS ACP System | Jan 05, 2017 | Substantially Equivalent | CORENTEC CO., LTD |
| K160982 | Sphynx | Dec 22, 2016 | Substantially Equivalent | Eden Spine LLC |
| K162638 | CETRA Anterior Cervical Plate System | Dec 16, 2016 | Substantially Equivalent | Orthofix Inc. |
| K162194 | MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System | Dec 08, 2016 | Substantially Equivalent | MEDICREA INTERNATIONAL S.A |
| K162211 | AccuFit Lateral Plate System | Nov 28, 2016 | Substantially Equivalent | PRECISION SPINE, INC. |
| K162250 | FortiBridge Anterior Cervical Plate System | Oct 26, 2016 | Substantially Equivalent | NANOVIS SPINE LLC |
| K162664 | Pyrenees Cervical Plate System | Oct 07, 2016 | Substantially Equivalent | K2M, Inc. |
| K161524 | Tangis Anterior Cervical Plate | Sep 02, 2016 | Substantially Equivalent | NVISION BIOMEDICAL TECHNOLOGIES, LLC |
| K160702 | ZION Anterior Cervical Fixation System | Aug 23, 2016 | Substantially Equivalent | Astura Medical |
| K153097 | Belvedere Lateral Plating System | Jul 15, 2016 | Substantially Equivalent | NEUROSTRUCTURES, INC. |
| K160604 | Cure Anterior Cervical Plate (ACP) System | Jul 01, 2016 | Substantially Equivalent | MEDITECH SPINE, LLC |
| K153526 | Pyrenees Cervical Plate System | Apr 27, 2016 | Substantially Equivalent | K2M |
| K160522 | White Pearl Preferred Angle Anterior Cervical Plate | Apr 26, 2016 | Substantially Equivalent | OSSEUS FUSION SYSTEMS, LLC |
| K153042 | TRYPTIK2C-plate Anterior Cervical Plate System | Mar 28, 2016 | Substantially Equivalent | SPINEART |
| K160362 | Z-Span Plate System | Mar 22, 2016 | Substantially Equivalent | Zavation, LLC |
| K151553 | Anterior Cervical Plate System | Feb 10, 2016 | Substantially Equivalent | Osteomed Implantes, LTDA |
| K152239 | Zero-P Natural Plate System | Dec 02, 2015 | Substantially Equivalent | Synthes (USA), LLC |
| K152282 | Cam Lock Plating System | Nov 20, 2015 | Substantially Equivalent | LIFE SPINE, INC |
| K152623 | ATLANTIS Anterior Cervical Plate System | Nov 12, 2015 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK USA, INC |
| K152455 | Amendia Cervical Plate System | Oct 15, 2015 | Substantially Equivalent | Amendia, Inc |
| K152193 | Renovis Anterior Cervical Plate System | Sep 25, 2015 | Substantially Equivalent | Renovis Surgical Technologies, Inc. |
| K152281 | Pyrenees Cervical Plate System | Sep 24, 2015 | Substantially Equivalent | K2M |
| K152015 | Pyrenees Cervical Plate System | Sep 04, 2015 | Substantially Equivalent | K2M, INC. |
| K150759 | Hyper-C Anterior Cervical Plate System | Jul 28, 2015 | Substantially Equivalent | Degen Medical |
| K150700 | ACP 1 Anterior Cervical Plating System | Jul 15, 2015 | Substantially Equivalent | STRYKER CORPORATION |
| K150983 | Pyrenees Cervical Plate System | Jul 14, 2015 | Substantially Equivalent | K2M |
| K150834 | Atrax Anterior Cervical Plating System | Jul 10, 2015 | Substantially Equivalent | X-Spine Systems, Inc |
| K143688 | ASFORA ANTERIOR CERVICAL PLATE SYSTEM | Jul 01, 2015 | Substantially Equivalent | MEDICAL DESIGNS, LLC |
| K143271 | CastleLoc-P Anterior Cervical Plate System | Jul 01, 2015 | Substantially Equivalent | L&K BIOMED Co., Ltd |
| K150666 | uNion Cervical Plate System | Jun 22, 2015 | Substantially Equivalent | ulrich medical USA |
| K141332 | Captiva Spine SmartLOX Cervical Plate System | Jun 11, 2015 | Substantially Equivalent | CAPTIVA SPINE |
| K143028 | Azure Anterior Cervical Plate System | May 29, 2015 | Substantially Equivalent | ORTHOFIX, INC. |
| K150036 | Blue Mountain Cervical Plate System | May 07, 2015 | Substantially Equivalent | SPINEWAY |
| K142212 | Pyrenees Cervical Plate System | May 01, 2015 | Substantially Equivalent | K2M, Inc |
| K143706 | FortiBridge Anterior Cervical Plate System | Apr 10, 2015 | Substantially Equivalent | Nanovis Spine LLC |
| K150449 | LITe Plate System | Mar 20, 2015 | Substantially Equivalent | STRYKER CORP. |
| K143626 | inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation System | Mar 20, 2015 | Substantially Equivalent | Zimmer Spine, Inc. |
| K143279 | LnK Anterior Cervical Plate System | Mar 20, 2015 | Substantially Equivalent | L&K BIOMED Co., Ltd. |
| K143576 | Exactech Ambassador | Feb 27, 2015 | Substantially Equivalent | EXACTECH, INC. |
| K142237 | Aviator Anterior Cervical Plate (ACP) System | Jan 26, 2015 | Substantially Equivalent | Stryker Corporation |
| K143065 | NuVasive ALIF Buttress Plate System | Jan 21, 2015 | Substantially Equivalent | NUVASIVE, INCORPORATED |
| K142699 | LITe Plate System | Dec 31, 2014 | Substantially Equivalent | STRYKER CORPORATION |
| K141632 | ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEM | Dec 04, 2014 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK USA, INC. |
| K142060 | TRANSOM ANTERIOR CERVICAL PLATE | Nov 18, 2014 | Substantially Equivalent | NEUROSTRUCTURES, INC. |
| K141993 | NAKOMA ACP | Nov 06, 2014 | Substantially Equivalent | ALLIANCE PARTNERS, LLC |
| K133518 | MAXAN ANTERIOR CERVICAL PLATE SYSTEM | Nov 05, 2014 | Substantially Equivalent | BIOMET SPINE (AKA EBI, LLC) |
| K133245 | GENESYS SPINE ANTERIOR CERVICAL PLATE II SYSTEM | Oct 08, 2014 | Substantially Equivalent | GENESYS SPINE |
| K141500 | OPTIO-C ANTERIOR CERVICAL SYSTEM | Sep 23, 2014 | Substantially Equivalent | ZIMMER SPINE, INC. |
| K133911 | GENESYS SPINE ANTERIOR BUTTRESS PLATE SYSTEM | Sep 03, 2014 | Substantially Equivalent | GENESYS SPINE |
| K140417 | DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM | Jul 09, 2014 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK, INC. |
| K140260 | SKYHAWK LATERAL PLATE SYSTEM | Jul 02, 2014 | Substantially Equivalent | ORTHOFIX INC. |
| K133194 | DIAMOND RATTLESNAKE SYSTEM | Jun 26, 2014 | Substantially Equivalent | EMINENT SPINE |
| K140361 | META-C CERVICAL PLATE | Jun 12, 2014 | Substantially Equivalent | MEDACTA INTERNATIONAL |
| K140234 | ASPIRON ACP SYSTEM | Jun 02, 2014 | Substantially Equivalent | U&I CORP. |
| K140611 | TRINICA ANTERIOR LUMBAR PLATE SYSTEM | May 21, 2014 | Substantially Equivalent | ZIMMER SPINE, INC. |
| K132653 | NEOPLATE SPINE ANTERIOR FIXATION SYSTEM | May 14, 2014 | Substantially Equivalent | NEOORTHO PRODUCTOS ORTHOPEDICOS S/A |
| K140742 | RELIANCE ANTERIOR CERVICAL PLATE | Apr 25, 2014 | Substantially Equivalent | Reliance Medical Systems, LLC |
| K133567 | UNIFY(R) DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM | Feb 20, 2014 | Substantially Equivalent | GLOBUS MEDICAL INC. |
| K131521 | VELOX ANTERIOR CERVICAL PLATE SYSTEM | Dec 24, 2013 | Substantially Equivalent | SPINECRAFT LLC |
| K132310 | ASCOT | Dec 23, 2013 | Substantially Equivalent | BACKROADS CONSULTING, INC. |
| K133475 | STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS | Dec 19, 2013 | Substantially Equivalent | NEXXT SPINE LLC |
| K132994 | ANODYNE ANTERIOR CERVICAL PLATE SYSTEM | Dec 05, 2013 | Substantially Equivalent | CORELINK LLC |
| K131025 | ARCHON ANTERIOR CERVICAL PLATE SYSTEM | Nov 27, 2013 | Substantially Equivalent | NUVASIVE, INC. |
| K131533 | CAYMAN MI PLATE SYSTEM | Nov 09, 2013 | Substantially Equivalent | K2M, INC. |
| K132589 | ANTERIOR LUMBAR PLATE SYSTEM (PRESIDIO) | Oct 08, 2013 | Substantially Equivalent | LIFE SPINE, INC |
| K132324 | SKYLINE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE 2 ANTERIOR CERVICAL PLATE SYST | Sep 06, 2013 | Substantially Equivalent | MEDOS INTERNATIONAL SARL |
| K132366 | SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS | Sep 03, 2013 | Substantially Equivalent | ACCEL SPINE |
| K132012 | TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT ANTERIOR CERVICAL PLATE SYSTEM | Aug 29, 2013 | Substantially Equivalent | ZIMMER SPINE, INC. |
| K131200 | ASPIRON ACP SYSTEM | Aug 29, 2013 | Substantially Equivalent | U & I CORPORATION |
| K130868 | NUVASIVE DECADE LATERAL PLATE SYSTEM | Aug 29, 2013 | Substantially Equivalent | NUVASIVE, INC. |
| K131374 | TEMPUS(TM) CERVICAL PLATE SYSTEM | Aug 23, 2013 | Substantially Equivalent | NEUROSTRUCTURES, LLC |
| K131512 | KATIA SYSTEM | Aug 07, 2013 | Substantially Equivalent | SHANGHAI SANYOU MEDICAL CO, LTD |
| K131520 | NEXUS ANTERIOR CERVICAL PLATE SYSTEM | Jul 11, 2013 | Substantially Equivalent | CORE-NEXUS |
| K130427 | PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM | Jun 05, 2013 | Substantially Equivalent | PIONEER SURGICAL TECHNOLOGY, INC. |
| K130640 | ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM | Jun 04, 2013 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK USA, INC. |
| K130825 | AZURE ANTERIOR CERVICAL PLATE SYSTEM | May 07, 2013 | Substantially Equivalent | ORTHOFIX, INC. |
| K130202 | IRIS ANTERIOR CERVICAL PLATE | Apr 29, 2013 | Substantially Equivalent | LIFE SPINE, INC |
| K130030 | ZAVATION CERVICAL PLATE SYSTEM | Apr 25, 2013 | Substantially Equivalent | ZAVATION LLC |
| K123578 | ANTERIOR CERVICAL PLATE SYSTEM | Feb 01, 2013 | Substantially Equivalent | WEIGAO ORTHOPAEDIC DEVICE CO., LTD |
| K122081 | NUVASIVE LONG LATERAL SPINAL SYSTEM | Feb 01, 2013 | Substantially Equivalent | NUVASIVE, INC. |
| K123167 | DEPUY PULSE ANTERIOR CERVICAL IN-LINE PLATE SYSTEM | Dec 28, 2012 | Substantially Equivalent | MEDOS INTERNATIONAL SARL |
| K121514 | ANODYNE ANTERIOR CERVICAL PLATE SYSTEM | Dec 14, 2012 | Substantially Equivalent | CORELINK LLC |
| K122733 | V2F ANTERIOR FIXATION SYSTEM | Dec 07, 2012 | Substantially Equivalent | ZIMMER SPINE, INC |
| K121791 | ZOU ANTERIOR LUMBAR PLATE SYSTEM | Nov 19, 2012 | Substantially Equivalent | CORELINK LLC |
| K121862 | REX ANTERIOR CERVICAL PLATE SYSTEM | Oct 31, 2012 | Substantially Equivalent | DIO MEDICAL CO., LTD. |
| K121815 | NUVASIVE SAGE LATERAL PLATE SYSTEM | Oct 23, 2012 | Substantially Equivalent | NUVASIVE, INC. |
| K122497 | ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MM | Oct 15, 2012 | Substantially Equivalent | MEDICAL DESIGN LLC. |
| K122910 | ARCHON ANTERIOR CERVICAL PLATE SYSTE, | Oct 11, 2012 | Substantially Equivalent | NUVASIVE, INCORPORATED |
| K121078 | VAN GOGH ANTERIOR CERVICAL PLATE SYSTEM | Sep 13, 2012 | Substantially Equivalent | ACCEL SPINE |
| K121801 | QUINTEX CERVICAL PLATING SYSTEM | Sep 11, 2012 | Substantially Equivalent | AESCULAP IMPLANT SYSTEMS, LLC |
| K122216 | RELIANCE ANTERIOR CERVICAL PLATE SYSTEM | Sep 05, 2012 | Substantially Equivalent | Reliance Medical Systems, LLC |
| K121658 | ORTHOFIX ACP (ANTERIOR CERVICAL PLATE SYSTEM) | Jul 20, 2012 | Substantially Equivalent | ORTHOFIX INC. |
| K121323 | MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE | Jul 18, 2012 | Substantially Equivalent | MEDICREA INTERNATIONAL |
| K121837 | NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM | Jul 16, 2012 | Substantially Equivalent | NUVASIVE, INC. |
| K112748 | SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM | Jul 11, 2012 | Substantially Equivalent | SPINAL USA LLC |
| K121060 | SPINE FRONTIER INDUS ACP SYSTEM | Jul 03, 2012 | Substantially Equivalent | SPINEFRONTIER, INC. |
| K121049 | UNIFY DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM | Jun 27, 2012 | Substantially Equivalent | GLOBUS MEDICAL INC. |
| K112809 | BLUE MOUNTAIN CERVICAL PLATE | Jun 20, 2012 | Substantially Equivalent | QUALGENIX LLC |
| K120515 | TEMPUS CERVICAL PLATE SYSTEM | May 23, 2012 | Substantially Equivalent | NEUROSTRUCTURES, LLC |
| K120724 | PIONEER LATERAL PLATE SYSTEM | May 07, 2012 | Substantially Equivalent | PIONEER SURGICAL TECHNOLOGY, INC |
| K120092 | PLYMOUTH THORACOLUMBAR PLATE SYSTEM | Apr 13, 2012 | Substantially Equivalent | GLOBUS MEDICAL INC. |
| K113170 | CERVICAL PLATE | Apr 06, 2012 | Substantially Equivalent | EISERTECH, LLC |
| K112861 | SINTEA PLUSTEK ANTERIOR CERVICAL PLATE SYSTEM | Feb 24, 2012 | Substantially Equivalent | SINTEA PLUSTEK, LLC |
| K112206 | CARDIFF ANTERIOR CERVICAL PLATE SYSTEM | Jan 25, 2012 | Substantially Equivalent | SEASPINE, INC. |
| K113509 | LEXUS ANTERIOR CERVICAL PLATE SYSTEM | Jan 20, 2012 | Substantially Equivalent | L&K BIOMED CO., LTD |
| K113329 | K2M, PYRENEES CERVICAL PLATE SYSTEM | Jan 17, 2012 | Substantially Equivalent | K2M, INC. |
| K111132 | GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEM | Dec 09, 2011 | Substantially Equivalent | GENESYS SPINE |
| K112533 | ZAVATION CERVICAL PLATE SYSTEM | Dec 08, 2011 | Substantially Equivalent | ZAVATION LLC |
| K112724 | DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM | Nov 21, 2011 | Substantially Equivalent | MEDOS INTERNATIONAL SARL |
| K111796 | INVIZIA ANTERIOR CERVICAL PLATE SYSTEM | Oct 27, 2011 | Substantially Equivalent | ZIMMER SPINE, INC. |
| K111528 | PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES | Aug 24, 2011 | Substantially Equivalent | PIONEER SURGICAL TECHNOLOGY, INC |
| K102406 | PASS ANTERIOR SPINAL SYSTEM | Aug 23, 2011 | Substantially Equivalent | MEDICREA TECHNOLOGIES |
| K111135 | PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES) | Aug 17, 2011 | Substantially Equivalent | K2M, INC. |
| K110990 | GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM | Jul 25, 2011 | Substantially Equivalent | GOLD STANDARD ORTHOPEDICS LLC |
| K111866 | NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM | Jul 22, 2011 | Substantially Equivalent | NUVASIVE, INC. |
| K111410 | NUVASIVE LONG LATERAL SPINAL SYSTEM | Jun 20, 2011 | Substantially Equivalent | NUVASIVE, INC. |
| K103423 | MIS ANTERIOR CERVICAL PLATING SYSTEM | Jun 01, 2011 | Substantially Equivalent | LIFE SPINE |
| K103505 | ALTUM ANTERIOR CERVICAL PLATE | Mar 15, 2011 | Substantially Equivalent | SPINECRAFT LLC |
| K102334 | TRANS1 AXIALIF PLUS | Mar 14, 2011 | Substantially Equivalent | TRANS1 INCORPORATED |
| K103750 | NUVASIVE TRAVERSE PLATE SYSTEM | Mar 03, 2011 | Substantially Equivalent | NUVASIVE, INC. |
| K103838 | FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM | Feb 15, 2011 | Substantially Equivalent | PRECISION SURGERY LTD. |
| K103819 | PSL ANTERIOR CERVICAL PLATE SYSTEM | Feb 15, 2011 | Substantially Equivalent | PRECISION SURGERY LTD. |
| K103491 | SKYLINE ANTERIOR CERVICAL PLATE SYSTEM | Feb 14, 2011 | Substantially Equivalent | A JOHNSON & JOHNSON COMPANY |
| K103137 | VENUS ANTERIOR CERVICAL PLATE | Feb 10, 2011 | Substantially Equivalent | VERTICOR, LTD |
| K101353 | GOLDEN GATE ANTERIOR PLATE SYSTEM | Feb 04, 2011 | Substantially Equivalent | ULRICH GMBH & CO. KG |
| K103393 | POLARIS SPINAL SYSTEM | Feb 02, 2011 | Substantially Equivalent | BIOMET SPINE |
| K103068 | KING COBRA ANTERIOR CERVICAL PLATE | Jan 14, 2011 | Substantially Equivalent | EMINENT SPINE |
| K103070 | GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM + | Jan 12, 2011 | Substantially Equivalent | G SURGICAL CO., LTD. |
| K102820 | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY | Nov 05, 2010 | Substantially Equivalent | ALPHATEC SPINE, INC. |
| K101848 | SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM | Oct 14, 2010 | Substantially Equivalent | SPINAL ELEMENTS, INC. |
| K102265 | LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM | Sep 29, 2010 | Substantially Equivalent | LDR SPINE USA |
| K100243 | QUINTEX CERVICAL PLATING SYSTEM | Sep 02, 2010 | Substantially Equivalent | AESCULAP IMPLANT SYSTEMS, LLC |
| K101255 | ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM | Jul 21, 2010 | Substantially Equivalent | ALPHATEC SPINE, INC. |
| K100708 | PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES | Jun 04, 2010 | Substantially Equivalent | PIONEER SURGICAL TECHNOLOGY |
| K092695 | TRANSCORP TRANS-PLATE ANTERIOR CERVICAL PLATE SYSTEM | May 21, 2010 | Substantially Equivalent | TRANSCORP, INC. |
| K090861 | MAMBO, MODEL CS 18XX-XX | May 21, 2010 | Substantially Equivalent | ULRICH GMBH & CO. KG |
| K101151 | REGENT ANTERIOR CERVICAL PLATE | May 19, 2010 | Substantially Equivalent | CUSTOM SPINE |
| K100265 | DIAMOND ANTERIOR CERVICAL PLATE SYSTEM | May 13, 2010 | Substantially Equivalent | AMENDIA, INC. |
| K100614 | HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES | May 04, 2010 | Substantially Equivalent | BLACKSTONE MEDICAL, INC. |
| K100215 | ARCHIMED REMEDY CERVICAL PLATE | Apr 07, 2010 | Substantially Equivalent | ARCHIMED, INC. |
| K092765 | LANX ANTERIOR PLATING SYSTEM | Apr 07, 2010 | Substantially Equivalent | LANX, INC. |
| K093776 | INDUS ANTERIOR CERVICAL PLATE SYSTEM | Mar 26, 2010 | Substantially Equivalent | SPINEFRONTIER, INC. |
| K092474 | PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS | Mar 11, 2010 | Substantially Equivalent | K2M, INC. |
| K093804 | NUVASIVE HELIX REVOLUTION ACP SYSTEM | Feb 19, 2010 | Substantially Equivalent | NUVASIVE, INC. |
| K100061 | CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX | Feb 12, 2010 | Substantially Equivalent | K2M, INC. |
| K100070 | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM | Feb 04, 2010 | Substantially Equivalent | DEPUY SPINE, INC. |
| K092531 | SPINE360 ANTERIOR CERVICAL PLATE SYSTEM | Feb 04, 2010 | Substantially Equivalent | SPINE 360 |
| K092360 | ACP4 SPINAL IMPLANT SYSTEM | Jan 22, 2010 | Substantially Equivalent | X-SPINE SYSTEMS, INC. |
| K092124 | AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II | Jan 21, 2010 | Substantially Equivalent | TRANS1 INCORPORATED |
| K093200 | LIFE SPINE LUMBAR PLATE SYSTEM | Jan 19, 2010 | Substantially Equivalent | LIFE SPINE |
| K091936 | BLADE ANTERIOR CERVICAL PLATE SYSTEM | Jan 19, 2010 | Substantially Equivalent | NEXXT MEDICAL INC |
| K091926 | CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM | Dec 22, 2009 | Substantially Equivalent | CHOICE SPINE, LP |
| K092659 | SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25 | Nov 17, 2009 | Substantially Equivalent | SPINAL USA |
| K092146 | XTEND ANTERIOR CERVICAL PLATE SYSTEM | Nov 16, 2009 | Substantially Equivalent | GLOBUS MEDICAL, INC. |
| K090751 | COMET ANTERIOR CERVICAL PLATE SYSTEM | Oct 23, 2009 | Substantially Equivalent | APOLLO SPINE, INC. |
| K092070 | INTERPLATE C | Oct 06, 2009 | Substantially Equivalent | RSB SPINE LLC. |
| K091134 | CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE | Aug 17, 2009 | Substantially Equivalent | CUSTOM SPINE, INC. |
| K092108 | TRUSS THORACOLUMBAR PLATE SYSTEM | Aug 13, 2009 | Substantially Equivalent | GLOBUS MEDICAL, INC. |
| K091396 | CARDO MEDICAL ANTERIOR CERVICAL PLATE SYSTEM | Aug 05, 2009 | Substantially Equivalent | CARDO MEDICAL CORP. |
| K091159 | SYNTHES ORACLE PLATE | Jul 10, 2009 | Substantially Equivalent | SYNTHES SPINE |
| K091044 | SPINAL USA ANTERIOR LUMBAR PLATE SYSTEM | Jul 09, 2009 | Substantially Equivalent | SPINAL USA |
| K091253 | THORACOLUMBAR PLATE, MODEL 1208-41FXX, LUMBER PLATE, MODEL 1208-41FXXL, SACRAL PLATE, MODEL 1208-41FXXS | Jun 04, 2009 | Substantially Equivalent | K2M, INC. |
| K090415 | EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM | Jun 01, 2009 | Substantially Equivalent | EMINENT SPINE |
| K091071 | NUVASIVE LATERAL PLATE SYSTEM | May 08, 2009 | Substantially Equivalent | NUVASIVE, INC. |
| K090222 | PIONEER LUMBAR PLATE SYSTEM | Apr 28, 2009 | Substantially Equivalent | PIONEER SURGICAL TECHNOLOGY |
| K090316 | MODIFICATION TO: LANX ANTERIOR CERVICAL PLATE SYSTEM | Apr 07, 2009 | Substantially Equivalent | LANX, INC. |
| K081770 | BLACK WIDOW ANTERIOR BUTTRESS PLATE | Apr 02, 2009 | Substantially Equivalent | OMNI SURGICAL, L.P. |
| K083020 | STRYKER SPINE REFLEX TRANSLATIONAL ANTERIOR CERVICAL PLATING SYSTEM | Mar 26, 2009 | Substantially Equivalent | STRYKER CORP. |
| K083562 | STRYKER SPINE NULOCK ANTERIOR CERVICAL PLATING SYSTEM | Mar 25, 2009 | Substantially Equivalent | STRYKER CORP. |
| K083341 | NUVASIVE HELIX-T ACP SYSTEM | Mar 20, 2009 | Substantially Equivalent | NUVASIVE, INC. |
| K083663 | PACP | Feb 25, 2009 | Substantially Equivalent | PIONEER SURGICAL TECHNOLOGY |
| K083338 | CARDIFF ANTERIOR CERVICAL PLATE SYSTEM | Feb 02, 2009 | Substantially Equivalent | SEASPINE, INC. |
| K081548 | ANTERIOR BUTTRESS PLATE | Jan 29, 2009 | Substantially Equivalent | SCIENT'X USA, INC. |
| K082504 | APOLLO ANTERIOR CERVICAL PLATE SYSTEM | Jan 27, 2009 | Substantially Equivalent | APOLLO SPINE, INC. |
| K081380 | THORACOLUMBAR, LUMBAR AND SACRAL PLATES AND 6.0 AND 7.0 MM BONE SCREWS | Nov 19, 2008 | Substantially Equivalent | K2M, INC. |
| K082187 | BIOMET ANTERIOR LUMBAR PLATE | Nov 13, 2008 | Substantially Equivalent | EBI, L.P. |
| K082821 | SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM | Oct 31, 2008 | Substantially Equivalent | SPINE SMITH PARTNERS L.P. |
| K082037 | SEEPLATE CERVICAL PLATE SYSTEM | Sep 26, 2008 | Substantially Equivalent | AMEDICA CORP. |
| K082070 | NUVASIVE LATERAL PLATE SYSTEM | Sep 24, 2008 | Substantially Equivalent | NUVASIVE, INC. |
| K082273 | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM | Sep 10, 2008 | Substantially Equivalent | DEPUY SPINE, INC. |
| K081568 | ANTEGRA-T | Sep 02, 2008 | Substantially Equivalent | SYNTHES SPINE CO.LP |
| K081038 | ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM | Aug 15, 2008 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK |
| K081418 | SPINAL ELEMENTS BUTTRESS PLATE SYSTEM | Jul 14, 2008 | Substantially Equivalent | SPINAL ELEMENTS, INC. |
| K081132 | SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM | Jul 14, 2008 | Substantially Equivalent | SPINE SMITH PARTNERS L.P. |
| K081567 | VERTEBRON SSP CERVICAL PLATING SYSTEM | Jul 03, 2008 | Substantially Equivalent | VERTEBRON, INC. |
| K081391 | VIP ANTERIOR CERVICAL PLATE SYSTEM | Jul 03, 2008 | Substantially Equivalent | GLOBUS MEDICAL, INC. |
| K073500 | ACTIVE ANTERIOR CERVICAL PLATE SYSTEM | Jul 03, 2008 | Substantially Equivalent | SANACOR |
| K080773 | THOR ANTERIOR PLATING SYSTEM | Jun 09, 2008 | Substantially Equivalent | STRYKER SPINE |
| K073708 | FIXED, VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM | Jun 03, 2008 | Substantially Equivalent | PRECISION SURGERY LTD. |
| K080020 | ARCOFIX | May 23, 2008 | Substantially Equivalent | SYNTHES SPINE CO.LP |
| K080646 | C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM | May 02, 2008 | Substantially Equivalent | BIOMET SPINE |
| K080429 | MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM | Apr 30, 2008 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK USA, INC. |
| K073643 | TRANS1 AXIALIF 2-LEVEL OR II SYSTEM | Apr 28, 2008 | Substantially Equivalent | TRANS1 INCORPORATED |
| K080690 | MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM | Apr 25, 2008 | Substantially Equivalent | THEKEN SPINE LLC |
| K080815 | TOSCA II ANTERIOR CERVICAL PLATE SYSTEM | Apr 23, 2008 | Substantially Equivalent | SIGNUS MEDIZINTECHNIK GMBH |
| K080191 | EAGLE PLUS MICRO ANTERIOR CERVICAL PLATE SYSTEM | Apr 02, 2008 | Substantially Equivalent | DEPUY SPINE, INC. |
| K080302 | CAYMAN BUTTRESS PLATE SYSTEM | Mar 24, 2008 | Substantially Equivalent | K2M, INC. |
| K073232 | INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX | Feb 20, 2008 | Substantially Equivalent | SPINEFRONTIER, INC. |
| K073437 | THOR ANTERIOR PLATING SYSTEM | Feb 13, 2008 | Substantially Equivalent | STRYKER SPINE |
| K073349 | RELIANCE BUTTRESS WASHER SYSTEM | Feb 13, 2008 | Substantially Equivalent | Reliance Medical Systems, LLC |
| K073530 | ACCIN ANTERIOR CERVICAL PLATE SYSTEM | Jan 31, 2008 | Substantially Equivalent | ACCELERATED INNOVATION, LLC |
| K073275 | NUVASIVE HELIX MINI ACP SYSTEM | Jan 29, 2008 | Substantially Equivalent | NUVASIVE, INC. |
| K072943 | BUTREX BUTTRESS PLATING SYSTEM | Jan 28, 2008 | Substantially Equivalent | X-SPINE SYSTEMS, INC. |
| K073514 | TRANS1 AXIAL FIXATON SYSTEM | Jan 11, 2008 | Substantially Equivalent | TRANS1 INCORPORATED |
| K072703 | PIONEER SLIMFUSE ANTERIOR CERVICAL PLATING SYSTEM | Jan 10, 2008 | Substantially Equivalent | PIONEER SURGICAL TECHNOLOGY |
| K073479 | KINETIC-SL ANTERIOR CERVICAL PLATE SYSTEM | Jan 09, 2008 | Substantially Equivalent | LIFE SPINE |
| K071905 | POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) | Dec 28, 2007 | Substantially Equivalent | LANX, LLC |
| K072231 | THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE) | Dec 26, 2007 | Substantially Equivalent | ESM TECHNOLOGIES, LLC. |
| K072407 | BODYFORM THORACIC FIXATION SYSTEM | Dec 21, 2007 | Substantially Equivalent | THEKEN SPINE LLC |
| K071667 | SYNTHES VECTRA-ONE SYSTEM | Nov 30, 2007 | Substantially Equivalent | SYNTHES SPINE |
| K072650 | IST ANTERIOR CERVICAL PLATE SYSTEM | Nov 28, 2007 | Substantially Equivalent | INNOVATIVE SPINAL TECHNOLOGIES INC |
| K071151 | TENSION BAND ANTERIOR SPINAL SYSTEM | Nov 07, 2007 | Substantially Equivalent | SPINAL INSTRUMENTATION SIMPLIFICATION SYSTEMS LLC |
| K071416 | PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM | Nov 01, 2007 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK USA, INC. |
| K071990 | VALEO CERVICAL PLATE SYSTEM | Oct 29, 2007 | Substantially Equivalent | AMEDICA CORP. |
| K072339 | NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM | Oct 19, 2007 | Substantially Equivalent | NUVASIVE, INC. |
| K072546 | SWIFT PLUS ANTERIOR CERVICAL PLATE SYSTEM | Oct 05, 2007 | Substantially Equivalent | DEPUY SPINE,INC |
| K070922 | MODIFICATION TO SPINAL USA VBR SYSTEM | Sep 19, 2007 | Substantially Equivalent | SPINAL USA |
| K071329 | NUVASIVE HELIX ACP SYSTEM | Aug 08, 2007 | Substantially Equivalent | NUVASIVE, INC. |
| K072040 | C-JAWS CERVICAL COMPRESSIVE MINI FRAME | Aug 03, 2007 | Substantially Equivalent | MEDICREA TECHNOLOGIES |
| K070148 | GRAFT CONTAINMENT DEVICE | Jul 31, 2007 | Substantially Equivalent | NUVASIVE, INC. |
| K070891 | ALTIVA CLASSIC ACP SYSTEM | Jun 11, 2007 | Substantially Equivalent | ALTIVA CORP. |
| K061385 | OSSTAPLE, OSSPLATE, OSSFORCE | May 30, 2007 | Substantially Equivalent | BIOMEDICAL ENTERPRISES, INC |
| K063764 | SOUTHERN SPINE ANTERIOR CERVICAL STABILIZATION SYSTEM, KWIK- FIX CERVICAL SYSTEM, AND KWIK-FIX / TS CERVICAL SYSTEM | May 16, 2007 | Substantially Equivalent | SOUTHERN SPINE, LLC |
| K070994 | EAGLE + ANTERIOR CERVICAL PLATE SYSTEM | May 09, 2007 | Substantially Equivalent | DEPUY SPINE, INC. |
| K070681 | NEXT GENERATION ANTERIOR CERVICAL PLATING SYSTEM | May 04, 2007 | Substantially Equivalent | ALPHATEC SPINE, INC. |
| K070775 | MODIFICATION TO: PROVIDENCE ANTERIOR CERVICAL PLATE SYSTEM | Apr 19, 2007 | Substantially Equivalent | GLOBUS MEDICAL INC. |
| K070335 | SIMPLEX CERVICAL FIXATION SYSTEM | Apr 16, 2007 | Substantially Equivalent | PISHARODI SURGICALS, INC. |
| K070273 | MODIFICATION TO NUVASIVE LATERAL PLATE SYSTEM | Apr 03, 2007 | Substantially Equivalent | NUVASIVE, INC. |
| K063430 | ZERO PROFILE ANTERIOR CERVICAL PLATE (ACP) SYSTEM | Mar 22, 2007 | Substantially Equivalent | STRYKER SPINE |
| K070285 | LIFE SPINE ANTERIOR CERVICAL PLATE SYSTEM | Mar 13, 2007 | Substantially Equivalent | LIFE SPINE |
| K063100 | ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM, TRANSLATIONAL PLATE | Feb 23, 2007 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK, INC. |
| K063544 | MODIFICATION TO PYRENEES CERVICAL PLATE SYSTEM | Feb 14, 2007 | Substantially Equivalent | K2M, INC. |
| K062590 | NUVASIVE ACP4 SYSTEM | Jan 18, 2007 | Substantially Equivalent | NUVASIVE, INC. |
| K062836 | CITADEL ANTERIOR LUMBAR PLATE SYSTEM | Dec 19, 2006 | Substantially Equivalent | GLOBUS MEDICAL INC. |
| K062371 | PREVIEW ANTERIOR CERVICAL PLATE SYSTEM | Dec 04, 2006 | Substantially Equivalent | ALPHASPINE, INC. |
| K062643 | KINETIC ANTERIOR CERVICAL PLATE | Nov 16, 2006 | Substantially Equivalent | LIFE SPINE |
| K061002 | MAXIMA ANTERIOR CERVICAL PLATE SYSTEM | Nov 15, 2006 | Substantially Equivalent | U&I CORP. |
| K063158 | SYNTHES ANTEGRA SYSTEM | Nov 14, 2006 | Substantially Equivalent | SYNTHES SPINE CO.LP |
| K062831 | MODIFICATION TO LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM | Oct 19, 2006 | Substantially Equivalent | LIFE SPINE |
| K062686 | UNIVERSAL SPINAL ANTERIOR LOCKING PLATE SYSTEM | Oct 05, 2006 | Substantially Equivalent | ADVANCED SPINE TECHNOLOGY, INC. |
| K062407 | GATEWAY THORACOLUMBAR PLATE SYSTEM | Sep 06, 2006 | Substantially Equivalent | GLOBUS MEDICAL, INC. |
| K061353 | TRINICA ANTERIOR LUMBAR PLATE SYSTEM | Aug 30, 2006 | Substantially Equivalent | ZIMMER SPINE, INC. |
| K062310 | REFLEX HYBRID ACP SYSTEM | Aug 18, 2006 | Substantially Equivalent | STRYKER SPINE |
| K062110 | VERTEBRON SCP CERVICAL PLATE SYSTEM | Aug 16, 2006 | Substantially Equivalent | VERTEBRON, INC. |
| K061789 | LATERAL PLATE SYSTEM | Aug 10, 2006 | Substantially Equivalent | NUVASIVE, INC. |
| K061482 | ALTES BUTTRESS PLATING SYSTEM | Jul 26, 2006 | Substantially Equivalent | ALTIVA CORP. |
| K061229 | UNITY LX ANTEROLATERAL LUMBAR PLATE FIXATION SYSTEM | Jul 24, 2006 | Substantially Equivalent | BLACKSTONE MEDICAL, INC. |
| K061147 | OPTERYX ANTERIOR CERVICAL PLATE SYSTEM | Jun 30, 2006 | Substantially Equivalent | INNOVASIS, INC. |
| K061274 | VENTURE ANTERIOR CERVICAL PLATE SYSTEM | May 25, 2006 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK |
| K060442 | PYRENEES CERVICAL PLATE SYSTEM | May 15, 2006 | Substantially Equivalent | K2M, LLC |
| K060025 | SLIMPLICITY ANTERIOR CERVICAL PLATE SYSTEM | Apr 18, 2006 | Substantially Equivalent | SPINAL USA |
| K060491 | QUANTUM ANTERIOR CERVICAL PLATE SYSTEM | Mar 13, 2006 | Substantially Equivalent | QUANTUM ORTHOPEDICS, INC. |
| K060379 | EBI ANTERIOR CERVICAL PLATE SYSTEM | Mar 06, 2006 | Substantially Equivalent | EBI, L.P. |
| K053581 | NUVASIVE SMARTPLATE GRADIENT PLUS SYSTEM | Feb 17, 2006 | Substantially Equivalent | NUVASIVE, INC. |
| K052546 | AEGIS ANTERIOR LUMBAR PLATE SYSTEM | Feb 03, 2006 | Substantially Equivalent | DEPUY SPINE, INC. |
| K053053 | PACP SYSTEM | Nov 16, 2005 | Substantially Equivalent | PIONEER SURGICAL TECHNOLOGY |
| K052763 | STELLA CERVICAL PLATE | Nov 10, 2005 | Substantially Equivalent | SCIENT'X |
| K052292 | SPIDER CERVICAL PLATING (SCP) SYSTEM | Oct 21, 2005 | Substantially Equivalent | X-SPINE SYSTEMS, INC. |
| K051815 | MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM | Oct 17, 2005 | Substantially Equivalent | VERTEBRON, INC. |
| K051531 | TECTONIC CERVICAL PLATE SYSTEM | Oct 17, 2005 | Substantially Equivalent | K2M, LLC |
| K052552 | HYBRID ANTERIOR CERVICAL PLATE SYSTEM | Oct 13, 2005 | Substantially Equivalent | DEPUY SPINE, INC. |
| K051665 | SYNTHES VECTRA-T SYSTEM | Sep 09, 2005 | Substantially Equivalent | SYNTHES SPINE |
| K052072 | THE SC-ACUFIX ANT-CER DYNAMIC CERVICAL PLATE SYSTEM SINGLE LEVEL PLATES | Aug 29, 2005 | Substantially Equivalent | ABBOTT SPINE, INC. |
| K051971 | OPTIMA SPINAL SYSTEM | Aug 04, 2005 | Substantially Equivalent | U&I CORP. |
| K051764 | T-PLATE ANTERIOR FIXATION SYSTEM | Jul 13, 2005 | Substantially Equivalent | ESM TECHNOLOGIES |
| K050965 | TRANS1 AXIALIF SYSTEM | Jun 14, 2005 | Substantially Equivalent | TRANS1 INCORPORATED |
| K043548 | BLACKSTONE UNITY ANTERIOR LUMBAR PLATE FIXATION SYSTEM | Jun 14, 2005 | Substantially Equivalent | BLACKSTONE MEDICAL, INC. |
| K051039 | BASIS SPINAL SYSTEM | May 12, 2005 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK USA, INC. |
| K050892 | HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM | May 11, 2005 | Substantially Equivalent | BLACKSTONE MEDICAL, INC. |
| K050813 | ABC 2 SCREW | May 04, 2005 | Substantially Equivalent | AESCULAP, INC. |
| K050588 | VERTEVIEW ANTERIOR CERVICAL PLATE SYSTEM | Apr 21, 2005 | Substantially Equivalent | INNOVATIVE SPINAL DESIGN, LLC |
| K050804 | MODIFICATION TO: SPECTRUMTM CERVICAL SPINAL SYSTEM | Apr 11, 2005 | Substantially Equivalent | AESCULAP, INC. |
| K050774 | LANX ANTERIOR CERVICAL PLATE SYSTEM | Apr 11, 2005 | Substantially Equivalent | LANX, LLC |
| K050451 | SYNTHES VECTRA SYSTEM | Mar 24, 2005 | Substantially Equivalent | SYNTHES SPINE CO.LP |
| K050390 | TAMARACK ANTERIOR THORACOLUNBAR | Mar 14, 2005 | Substantially Equivalent | ALPHATEC/NEXMED |
| K050117 | MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM | Feb 17, 2005 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK |
| K042073 | OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM | Feb 07, 2005 | Substantially Equivalent | OLSEN MEDICAL |
| K043066 | PIONEER ANTERIOR CERVICAL PLATE SYSTEM | Feb 03, 2005 | Substantially Equivalent | PIONEER SURGICAL TECHNOLOGY |
| K043151 | MODIFICATION TO: CD HORIZON SPINAL SYSTEM | Feb 01, 2005 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK |
| K031782 | GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICS | Feb 01, 2005 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK |
| K043181 | MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM | Dec 17, 2004 | Substantially Equivalent | VERTEBRON, INC. |
| K040426 | TRANS1 AXIAL FIXATION SYSTEM | Dec 17, 2004 | Substantially Equivalent | TRANS1, INC. |
| K042859 | KOBRA GPS FIXATION SYSTEM | Nov 24, 2004 | Substantially Equivalent | MEDTRONIC VERTELINK, INC. |
| K043082 | THE TOSCA ANTERIOR CERVICAL PLATE SYSTEM | Nov 23, 2004 | Substantially Equivalent | SIGNUS MEDIZINTECHNIK GMBH |
| K042544 | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM | Nov 23, 2004 | Substantially Equivalent | DEPUY SPINE, INC. |
| K042922 | VENTURE ANTERIOR CERVICAL PLATING SYSTEM | Nov 19, 2004 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK, INC. |
| K042798 | C-TEK C-TRUN ANTERIOR CERVICAL PLATE SYSTEM | Nov 04, 2004 | Substantially Equivalent | INTERPORE CROSS INTL. |
| K042499 | ORION ANTERIOR CERVICAL PLATING SYSTEM | Oct 07, 2004 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK |
| K042317 | CERVICAL PLATE | Sep 24, 2004 | Substantially Equivalent | SCIENT'X |
| K042235 | ORION ANTERIOR CERVICAL PLATING SYSTEM | Sep 17, 2004 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK |
| K041989 | SINTEA BIOTECH ANTERIOR PLATE SYSTEM, MODEL ACP.XX.T5.X | Sep 16, 2004 | Substantially Equivalent | SINTEA BIOTECH, INC. |
| K041625 | LTD POLYAXIAL FIXATION SYSTEM | Sep 08, 2004 | Substantially Equivalent | U.S. SPINAL TECHNOLOGIES, LLC. |
| K042025 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | Aug 25, 2004 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK, INC. |
| K041205 | EXPEDIUM ANTERIOR SPINE SYSTEM | Aug 17, 2004 | Substantially Equivalent | DEPUY SPINE, INC. |
| K041447 | NUVASIVE ANTERIOR CERVICAL PLATE SYSTEM | Aug 16, 2004 | Substantially Equivalent | NUVASIVE, INC. |
| K041469 | ANTERIOR COMPACT SYSTEM | Jul 30, 2004 | Substantially Equivalent | X-SPINE SYSTEMS |
| K041105 | MACROPORE HYDROSORB SPINE SYSTEM | Jul 28, 2004 | Substantially Equivalent | MACROPORE BIOSURGERY, INC. |
| K040844 | LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM | Jul 23, 2004 | Substantially Equivalent | LIFE SPINE, LLC. |
| K041794 | C-TEK C-THRU ANTERIOR CERVICAL PLATE SYSTEM | Jul 19, 2004 | Substantially Equivalent | INTERPORE CROSS INTL. |
| K041460 | CD HORIZON SPINAL SYSTEM | Jul 01, 2004 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK USA, INC. |
| K033951 | RADIX CERVICAL PLATE | Jul 01, 2004 | Substantially Equivalent | PISHARODI SURGICALS, INC. |
| K040721 | ASSURE ANTERIOR CERVICAL PLATE SYSTEM | Jun 17, 2004 | Substantially Equivalent | GLOBUS MEDICAL, INC. |
| K040655 | SWIFT ANTERIOR CERVICAL PLATE SYSTEM | Jun 02, 2004 | Substantially Equivalent | DEPUY SPINE,INC |
| K041217 | MODIFICATION TO BONE GRAFT WASHER | May 28, 2004 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK, INC. |
| K040962 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | May 14, 2004 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK |
| K040017 | ABC CAUDAL AND CRANIAL EXTENSION PLATE (E-PLATE) | May 14, 2004 | Substantially Equivalent | AESCULAP, INC. |
| K040397 | MODIFICATION TO CYCLONE ANTERIOR CERVICAL PLATE SYSTEM | May 06, 2004 | Substantially Equivalent | ENCORE MEDICAL, L.P. |
| K040261 | REFLEX HYBRID ANTERIOR CERVICAL PLATE SYSTEM | Apr 16, 2004 | Substantially Equivalent | STRYKER SPINE |
| K040401 | LANX ANTERIOR CERVIAL PLATE SYSTEM | Apr 12, 2004 | Substantially Equivalent | LANX, LLC |
| K033148 | ART ANTERIOR SPINAL SYSTEM | Apr 12, 2004 | Substantially Equivalent | ADVANCED MEDICAL TECHNOLOGIES AG |
| K040197 | EAGLE ANTERIOR CERVIAL PLATE SYSTEM | Apr 02, 2004 | Substantially Equivalent | DEPUY ACROMED |
| K040130 | ANTERIOR LUMBAR BUTTRESS SYSTEM | Mar 26, 2004 | Substantially Equivalent | SEASPINE |
| K040003 | VERTEBRON SCP CERVICAL PLATE SYSTEM | Mar 26, 2004 | Substantially Equivalent | VERTEBRON, INC. |
| K033965 | SHIRAZ-ANTERIOR SYSTEM | Mar 04, 2004 | Substantially Equivalent | SPINE NEXT AMERICA |
| K031100 | SYNTHES VENTROFIX MIS SYSTEM | Mar 04, 2004 | Substantially Equivalent | SYNTHES (USA) |
| K032815 | PRECISION SURGERY LIMITED VARIABLE AND FIXED CERVICAL PLATE SYSTEM | Feb 12, 2004 | Substantially Equivalent | PRECISION SURGERY LIMITED |
| K033844 | SYNTHES ANTERIOR CERVICAL COMPRESSION SYSTEM | Feb 05, 2004 | Substantially Equivalent | SYNTHES (USA) |
| K032102 | VERTELINK KOBRA SPINAL FIXATION SYSTEM | Dec 12, 2003 | Substantially Equivalent | VERTELINK CORPORATION |
| K032752 | R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM | Dec 03, 2003 | Substantially Equivalent | R&B SURGICAL SOLUTIONS, LLC. |
| K032368 | SONOMA ANTERIOR CERVICAL PLATE SYSTEM | Oct 09, 2003 | Substantially Equivalent | SEASPINE |
| K031214 | CYCLONE ANTERIOR CERVICAL PLATE SYSTEM | Sep 23, 2003 | Substantially Equivalent | ENCORE MEDICAL, L.P. |
| K024125 | HALM ZIELKE INSTRUMENTATION SYSTEM | Sep 22, 2003 | Substantially Equivalent | MICOMED ORTHO GMBH |
| K023983 | MODIFICATION TO HIGHGATE CURVED ROD SYSTEM | Sep 22, 2003 | Substantially Equivalent | HIGHGATE ORTHOPAEDICS |
| K031855 | SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM | Sep 17, 2003 | Substantially Equivalent | SPINAL CONCEPTS, INC. |
| K032265 | CD HORIZON SPINAL SYSTEM | Aug 11, 2003 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK |
| K031702 | REFLEX ANTERIOR CERVICAL PLATE SYSTEM | Aug 08, 2003 | Substantially Equivalent | HOWMEDICA OSTEONICS |
| K032059 | MODIFICATION TO MACS MODULAR ANTERIOR CONSTRUCT SYSTEM | Jul 25, 2003 | Substantially Equivalent | AESCULAP, INC. |
| K031276 | SYNTHES ANTERIOR CERVICAL LOCKING PLATE (ACLP) SYSTEM | Jul 02, 2003 | Substantially Equivalent | SYNTHES (USA) |
| K021979 | SMISSON STABILIZATION SYSTEM | Jun 27, 2003 | Substantially Equivalent | SMISSON-CARTLEDGE |
| K030667 | ENCORE ANTERIOR SPINAL STAPLE SYSTEM | May 28, 2003 | Substantially Equivalent | ENCORE MEDICAL, L.P. |
| K030595 | BLACKSTONE FUSION ANTERIOR CERVICAL PLATING SYSTEM | Apr 24, 2003 | Substantially Equivalent | BLACKSTONE MEDICAL, INC. |
| K030866 | SYNTHES ANTERIOR CSLP SYSTEM | Apr 18, 2003 | Substantially Equivalent | SYNTHES (USA) |
| K022965 | BLACKSTONE CLASSIC ANTERIOR CERVICAL PLATE | Mar 28, 2003 | Substantially Equivalent | BLACKSTONE MEDICAL, INC. |
| K030500 | ORIA ZENITH | Mar 20, 2003 | Substantially Equivalent | ORTHOTEC, L.L.C. |
| K023377 | ORIA CERVICAL PLATES | Mar 04, 2003 | Substantially Equivalent | ORTHOTEC, L.L.C. |
| K030327 | ZEPHIR ANTERIOR CERVICAL SYSTEM | Feb 26, 2003 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK |
| K024326 | SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM | Jan 23, 2003 | Substantially Equivalent | SPINAL CONCEPTS, INC. |
| K021039 | BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM | Dec 11, 2002 | Substantially Equivalent | DEPUYACROMED |
| K022997 | SPECTRUM CERVICAL SPINAL SYSTEM | Dec 06, 2002 | Substantially Equivalent | SPINAL INNOVATIONS, LLC. |
| K022798 | CERVIVE ANTERIOR CERVICAL PLATING SYSTEM, MODEL NUMBER 157.XXX SERIES CATALOGUE NUMBERS | Nov 19, 2002 | Substantially Equivalent | CORIN U.S.A. |
| K022791 | SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM | Nov 13, 2002 | Substantially Equivalent | SYNTHES (USA) |
| K021564 | INCOMPASS SPINAL FIXATION SYSTEM | Oct 25, 2002 | Substantially Equivalent | SPINAL CONCEPTS, INC. |
| K023133 | MODIFICATION TO EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM | Oct 18, 2002 | Substantially Equivalent | EBI, L.P. |
| K022344 | TRINICA SELECT ANTERIOR CERVICAL PLATE SYSTEM | Sep 24, 2002 | Substantially Equivalent | CENTERPULSE SPINE-TECH, INC. |
| K021761 | PREMIER ANTERIOR CERVICAL PLATE SYSTEM | Sep 17, 2002 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK |
| K022605 | BLACKSTONE SPINAL FIXATION SYSTEM STAPLE & WASHER | Aug 21, 2002 | Substantially Equivalent | BLACKSTONE MEDICAL, INC. |
| K022419 | EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM | Aug 12, 2002 | Substantially Equivalent | EBI, L.P. |
| K022399 | BLACKSTONE SPINAL FIXATION SYSTEM SPACER | Aug 06, 2002 | Substantially Equivalent | BLACKSTONE MEDICAL, INC. |
| K021461 | ATLANTIS VISION ANTERIOR CERVICAL PLATE SYSTEM | Jul 22, 2002 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK |
| K020620 | BLACKSTONE III DEGREE ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER) | May 23, 2002 | Substantially Equivalent | BLACKSTONE MEDICAL, INC. |
| K020600 | BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER) | May 22, 2002 | Substantially Equivalent | BLACKSTONE MEDICAL, INC. |
| K021226 | MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM | May 13, 2002 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK |
| K020244 | SYNTHES THORACOLUMBAR SPINE LOCKING PLATE (TSLP) | Apr 22, 2002 | Substantially Equivalent | SYNTHES SPINE |
| K020649 | ENVISION ANTERIOR CERVICAL PLATE SYSTEM | Apr 05, 2002 | Substantially Equivalent | ORTHO DEVELOPMENT CORP. |
| K020650 | MODIFICATION TO REFLEX ANTERIOR CERVICAL PLATE SYSTEM | Mar 29, 2002 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K012045 | HIGHGATE CURVED ROD SYSTEM | Mar 12, 2002 | Substantially Equivalent | HIGHGATE ORTHOPAEDICS |
| K014107 | ENDIUS CERVICAL PLATE SYSTEM | Feb 13, 2002 | Substantially Equivalent | ENDIUS, INC. |
| K013979 | SC-ACUFIX THINLINE ANTERIOR CERVICAL PLATE SYSTEM | Feb 13, 2002 | Substantially Equivalent | SPINAL CONCEPTS, INC. |
| K012184 | BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM | Jan 30, 2002 | Substantially Equivalent | BLACKSTONE MEDICAL, INC. |
| K013665 | PYRAMID ANTERIOR PLATE FIXATION SYSTEM | Jan 29, 2002 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK, INC. |
| K013558 | BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW | Jan 23, 2002 | Substantially Equivalent | BLACKSTONE MEDICAL, INC. |
| K013439 | ANTERIOR CERVICAL PLATE SYSTEM | Jan 14, 2002 | Substantially Equivalent | SCIEN'TX USA INC. |
| K013877 | CODMAN SLIM-LOC SYSTEM | Dec 19, 2001 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K012916 | FRONTIER ANTERIOR SCOLIOSIS SYSTEM | Nov 27, 2001 | Substantially Equivalent | DEPUY ACROMED, INC. |
| K012881 | C3 ANTERIOR CERVICAL PLATE SYSTEM | Nov 26, 2001 | Substantially Equivalent | SPINE VISION, INC |
| K011556 | MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM | Nov 16, 2001 | Substantially Equivalent | AESCULAP, INC. |
| K012305 | MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM | Aug 22, 2001 | Substantially Equivalent | SULZER SPINE-TECH |
| K010911 | MACROPORE OS SPINAL SYSTEM | Jul 20, 2001 | Substantially Equivalent | MACROPORE BIOSURGERY, INC. |
| K010639 | CONVERGENCE CERVICAL SPINAL SYSTEM | May 30, 2001 | Substantially Equivalent | SPINAL INNOVATIONS, LLC. |
| K010466 | TETHER ACFS | May 16, 2001 | Substantially Equivalent | THEKEN SURGICAL,LLC |
| K002824 | MACS MODULAR ANTERIOR CONSTRUCT SYSTEM | May 08, 2001 | Substantially Equivalent | AESCULAP, INC. |
| K010115 | REFLEX ANTERIOR CERVICAL PLATE SYSTEM | Apr 16, 2001 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K010003 | EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM | Jan 31, 2001 | Substantially Equivalent | EBI, L.P. |
| K003061 | SYNTHES USS (10.0MM SIDE OPENING SCREWS) | Oct 30, 2000 | Substantially Equivalent | SYNTHES |
| K002980 | MODIFICATION TO EBI ANTERIOR CERVICAL PLATE SYSTEM | Oct 23, 2000 | Substantially Equivalent | EBI, L.P. |
| K002858 | XIA SPINE SYSTEM | Oct 13, 2000 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K002592 | INTERPORE CROSS ANTERIOR CERVICAL PLATE SYSTEM | Oct 06, 2000 | Substantially Equivalent | INTERPORE CROSS INTL. |
| K002371 | K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM | Sep 15, 2000 | Substantially Equivalent | SPINEOLOGY, INC. |
| K001847 | ANTERIOR CERVICAL PLATE SYSTEM | Aug 24, 2000 | Substantially Equivalent | ENCORE ORTHOPEDICS, INC. |
| K001864 | SYNTHES CERVIFIX SYSTEM | Jul 20, 2000 | Substantially Equivalent | SYNTHES SPINE |
| K001357 | MODIFICATION TO OMEGA 21 SYSTEM | Jul 20, 2000 | Substantially Equivalent | EBI, L.P. |
| K001844 | MODIFICATION TO CENTAUR SPINAL SYSTEM | Jul 19, 2000 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K001794 | EBI ANTERIOR CERVICAL PLATE SYSTEM | Jul 12, 2000 | Substantially Equivalent for Some Indications | EBI, L.P. |
| K994239 | ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM | Jun 19, 2000 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK, INC. |
| K993066 | WINDOW CERVICAL DYNAMIC PLATE SYSTEM | Jun 07, 2000 | Substantially Equivalent | ADVANCED SPINE TECHNOLOGY, INC. |
| K001272 | XIA SPINE SYSTEM | May 11, 2000 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K993513 | DELTALOC ANTERIOR CERVICAL PLATE SYSTEM | Apr 26, 2000 | Substantially Equivalent | ALPHATEC MFG., INC. |
| K000486 | ABC CERVICAL PLATING SYSTEM | Apr 14, 2000 | Substantially Equivalent | AESCULAP, INC. |
| K000742 | SYNTHES ANTERIOR CSLP SYSTEM | Mar 29, 2000 | Substantially Equivalent | SYNTHES SPINE |
| K994347 | CENTAUR SPINAL SYSTEM | Mar 15, 2000 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K000536 | SYNTHES ANTERIOR CSLP SYSTEM | Mar 15, 2000 | Substantially Equivalent | SYNTHES SPINE |
| K000634 | ROD TO ROD CROSS BRACES | Mar 10, 2000 | Substantially Equivalent | CORIN U.S.A. |
| K000009 | SPIRAL RADIUS RODDING SYSTEM | Mar 10, 2000 | Substantially Equivalent | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K000513 | MODIFICATION TO EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM | Mar 07, 2000 | Substantially Equivalent | EBI, L.P. |
| K994122 | BONE GRAFT WASHER, MODEL 9090114 - 9090118 | Feb 18, 2000 | Substantially Equivalent | DANEK MEDICAL, INC. |
| K994383 | DOGBONE ACFS | Feb 04, 2000 | Substantially Equivalent | THEKEN SURGICAL |
| K992012 | WILTSE SYSTEM | Feb 04, 2000 | Substantially Equivalent | ADVANCED SPINE FIXATION SYSTEMS, INC. |
| K993030 | MODIFICATION TO ISOLA SPINAL SYSTEM | Dec 29, 1999 | Substantially Equivalent | DEPUY ACROMED |
| K990959 | K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM | Dec 27, 1999 | Substantially Equivalent | SPINEOLOGY, INC. |
| K993855 | ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM | Dec 15, 1999 | Substantially Equivalent | DANEK MEDICAL, INC. |
| K993822 | EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM | Dec 10, 1999 | Substantially Equivalent | EBI, L.P. |
| K992792 | XIA SPINAL SYSTEM C-C ADAPTOR | Nov 16, 1999 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K992784 | NEXT GENERATION RODDING SYSTEM | Oct 27, 1999 | Substantially Equivalent | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K993181 | HOWMEDICA OSTEONICS ACCP SYSTEM CORTICAL SCREWS | Oct 22, 1999 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K992168 | MOSS MIAMI 6.35MM POLYAXIAL SCREW | Sep 23, 1999 | Substantially Equivalent | DEPUY ACROMED |
| K992110 | PREMIER ANTERIOR CERVICAL PLATE SYSTEM | Sep 14, 1999 | Substantially Equivalent | SOFAMOR DANEK USA |
| K991678 | WHITESIDE BIOMECHANICS SPINAL SYSTEM | Aug 12, 1999 | Substantially Equivalent | WHITESIDE BIOMECHANICS, INC. |
| K992344 | OSTEONICS ACCP SYSTEM LINE EXTENSION | Jul 30, 1999 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K991092 | EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM | Apr 29, 1999 | Substantially Equivalent | ELECTRO-BIOLOGY, INC. |
| K982798 | OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM | Mar 25, 1999 | Substantially Equivalent | OSTEONICS CORP. |
| K990603 | MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM | Mar 10, 1999 | Substantially Equivalent | DANEK MEDICAL, INC. |
| K984251 | XIA SPINE SYSTEM | Feb 24, 1999 | Substantially Equivalent | HOWMEDICA, INC. |
| K990005 | SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM | Feb 12, 1999 | Substantially Equivalent | SPINAL CONCEPTS, INC. |
| K982006 | MICOMED - HALM ZIELKE INSTRUMENTATION | Jan 20, 1999 | Substantially Equivalent | MICOMED GMBH |
| K982875 | MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM | Jan 19, 1999 | Substantially Equivalent | DANEK MEDICAL, INC. |
| K984342 | ANTERIOR CERVICAL PLATING SYSTEM | Dec 30, 1998 | Substantially Equivalent | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K983622 | BODYFORM THORACO-LUMBAR FIXATION SYSTEM | Dec 30, 1998 | Substantially Equivalent | THEKEN SURGICAL,LLC |
| K983899 | THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER) | Dec 22, 1998 | Substantially Equivalent | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K982443 | DOC VENTRAL CERVICAL STABILIZATION SYSTEM | Jul 29, 1998 | Substantially Equivalent | DEPUY MOTECH ACROMED |
| K974885 | BLACKSTONE MEDICAL INC. ANTERIOR CERVICAL PLATE SYSTEM | Jun 17, 1998 | Substantially Equivalent | BLACKSTONE MEDICAL, INC. |
| K981008 | SIMAL CERVICAL STABILIZATION SYSTEM | May 27, 1998 | Substantially Equivalent | TOP SURGICAL PRODUCTS GMBH |
| K980228 | UNIVERSITY PLATE ANTERIOR SYSTEM | Apr 14, 1998 | Substantially Equivalent for Some Indications | ACROMED CORP. |
| K973854 | ORION ANTERIOR CERVICAL PLATE SYSTEM | Mar 16, 1998 | Substantially Equivalent for Some Indications | SOFAMOR DANEK USA,INC. |
| K974706 | AESCULAP ABC CERVICAL PLATING SYSTEM | Mar 13, 1998 | Substantially Equivalent for Some Indications | AESCULAP, INC. |
| K974757 | KANEDA ANTERIOR SCOLIOSIS SYSTEM KASS | Mar 05, 1998 | Substantially Equivalent for Some Indications | ACROMED CORP. |
| K974525 | SYNTHES SPINE ANTERIOR THORACOLUMBAR ROD CLAMP (ATRC) SYSTEM | Mar 02, 1998 | Substantially Equivalent for Some Indications | SYNTHES SPINE |
| K974435 | MICHELSON ANTERIOR CERVICAL PLATE SYSTEM | Feb 19, 1998 | Substantially Equivalent for Some Indications | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K973923 | EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM | Jan 13, 1998 | Substantially Equivalent for Some Indications | EBI ELECTRO BIOLOGY |
| K973060 | DEPUY MOTECH PROFILE ANTERIOR THORACOLUMBAR PLATE SYSTEM | Nov 03, 1997 | Substantially Equivalent for Some Indications | DEPUY, INC. |
| K971730 | DEPUY MOTECH PEAK POLYAXIAL ANTERIOR CERVICAL PLATE SYSTEM | Nov 03, 1997 | Substantially Equivalent for Some Indications | DEPUY, INC. |
| K971883 | SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM | Oct 16, 1997 | Substantially Equivalent | SYNTHES (USA) |
| K972718 | M-2 ANTERIOR PLATE SYSTEM | Oct 01, 1997 | Substantially Equivalent for Some Indications | ACROMED CORP. |
| K970635 | TITANIUM SPINAL ROD SYSTEM | Aug 14, 1997 | Substantially Equivalent | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. |
| K970048 | SYNTHES(USA)TITANIUM LOCKING PLATE SYSTEM(TILPS) | Aug 01, 1997 | Substantially Equivalent | SYNTHES (USA) |
| K963780 | DUAL ROD ANTERIOR FIXATOR SYSTEM | Jul 30, 1997 | Substantially Equivalent | SOFAMOR DANEK USA,INC. |
| K971248 | KANEDA SR ANTERIOR SPINAL SYSTEM | Jun 11, 1997 | Substantially Equivalent for Some Indications | ACROMED CORP. |
| K970955 | ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM | Jun 11, 1997 | Substantially Equivalent for Some Indications | ACROMED CORP. |
| K970806 | ACPII ANTERIOR CERVICAL PLATE SYSTEM | May 02, 1997 | Substantially Equivalent for Some Indications | SOFAMOR DANEK USA,INC. |
| K964797 | EBI SPINELINK SYSTEM | May 02, 1997 | Substantially Equivalent | ELECTRO-BIOLOGY, INC. |
| K970462 | ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM | Apr 03, 1997 | Substantially Equivalent | ACROMED CORP. |
| K965193 | LIBERTY ANTERIOR SPINAL SYSTEM | Mar 17, 1997 | Substantially Equivalent | SOFAMOR DANEK USA,INC. |
| K964416 | SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM | Mar 17, 1997 | Substantially Equivalent for Some Indications | SYNTHES (USA) |
| K953978 | ANTERIOR DYNAMIZED SYSTEM | Feb 19, 1997 | Substantially Equivalent | ACROMED CORP. |
| K964623 | TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEM | Feb 06, 1997 | Substantially Equivalent for Some Indications | SOFAMOR DANEK USA,INC. |
| K962486 | DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM | Dec 27, 1996 | Substantially Equivalent for Some Indications | DEPUY, INC. |
| K963655 | CD HORIZON ANTERIOR SPINAL SYSTEM | Nov 27, 1996 | Substantially Equivalent | SOFAMOR DANEK USA,INC. |
| K955730 | EBI ANTERIOR CERVICAL SPINE SYSTEM | Mar 13, 1996 | Substantially Equivalent for Some Indications | ELECTRO-BIOLOGY, INC. |
| K940744 | SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION | Jan 30, 1996 | Substantially Equivalent for Some Indications | SOFAMOR CO. |
| K953730 | CODMAN ANTERIOR CERVICAL PLATE SYSTEM | Nov 09, 1995 | Substantially Equivalent for Some Indications | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K950011 | COHORT(TM) ANTERIOR PLATE SYSTEM (APS) | Nov 06, 1995 | Substantially Equivalent for Some Indications | COHORT MEDICAL PRODUCTS GROUP, INC. |
| K953720 | AESCULAP CASPAR PLATE & SCREW SYSTEM FOR ANTERIOR CERVICAL FUSION | Nov 02, 1995 | Substantially Equivalent for Some Indications | AESCULAP, INC. |
| K950709 | SYNERGY TI ANTERIOR SPINAL SYSTEM | Oct 25, 1995 | Substantially Equivalent for Some Indications | CROSS MEDICAL PRODUCTS, INC. |
| K950209 | J.B.S. ANTERIOR SPINE SYSTEM(R) | Oct 11, 1995 | Substantially Equivalent for Some Indications | J.B.S. (USA), INC. |
| K943725 | UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM | Aug 25, 1995 | Substantially Equivalent for Some Indications | SYNTHES SPINE |
| K945700 | SYNTHES (USA) ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM | Jul 20, 1995 | Substantially Equivalent | SYNTHES (USA) |
| K943819 | ISOLA ANTERIOR SYSTEM | Feb 09, 1995 | Substantially Equivalent for Some Indications | ACROMED CORP. |
| K943694 | EBI ANTERIOR CERVICAL SPINE SYSTEM | Feb 08, 1995 | Substantially Equivalent for Some Indications | ELECTRO-BIOLOGY, INC. |
| K943523 | ANTERIOR CERVIAL PLATING SYSTEM | Dec 19, 1994 | Substantially Equivalent for Some Indications | SMITH & NEPHEW RICHARDS, INC. |
| K941367 | WEBB-MORLEY SPINE SYSTEM | Dec 05, 1994 | Substantially Equivalent for Some Indications | ELECTRO-BIOLOGY, INC. |
| K934756 | CODMAN ANTERIOR CERVICAL SPINE PLATE SYSTEM | Nov 08, 1994 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K934429 | ANTERIOR SPINE SYSTEM | Oct 20, 1994 | Substantially Equivalent | BUCKMAN CO., INC. |
| K936269 | CASPAR TITANIUM ALLOY BONE SCREWS | Aug 15, 1994 | Substantially Equivalent for Some Indications | AESCULAP, INC. |
| K931653 | SPINE-TECH CERVICAL FIXATION SYSTEM | Aug 04, 1994 | Substantially Equivalent | SPINAL TECHNOLOGIES |
| K925351 | SYNTHES(U.S.A.) ANTERIOR SPINAL PLATE | Nov 05, 1993 | Substantially Equivalent for Some Indications | SYNTHES (USA) |
| K926453 | SYNTHES (U.S.A.) ANTERIOR CERVICAL VERTEBRAE PLATE | Oct 12, 1993 | Substantially Equivalent for Some Indications | SYNTHES (USA) |
| K930807 | SENTRY ANTERIOR SPINAL SYSTEM | Oct 01, 1993 | Substantially Equivalent | SOFAMOR DANEK MFG., INC. |
| K922855 | SYNTHES UNIVERSAL SPINE ROD AND SCREW FIXATION SYS | Jun 24, 1993 | Substantially Equivalent | SYNTHES (USA) |
| K923703 | KANEDA ANTERIOR SPINAL MULTISEGMENTAL FIXATION DEV | May 20, 1993 | Substantially Equivalent for Some Indications | ACROMED CORP. |
| K923242 | CROSSLINK AXIAL AND OFFSET PLATES | May 19, 1993 | Substantially Equivalent for Some Indications | SOFAMOR DANEK MFG., INC. |
| K922543 | Z-PLATE ANTERIOR FIXATION SYSTEM | May 19, 1993 | Substantially Equivalent for Some Indications | SOFAMOR DANEK MFG., INC. |
| K923446 | STERILE DYNA LOK ANTERIOR PLATING SYSTEM | Dec 17, 1992 | Substantially Equivalent for Some Indications | SOFAMOR DANEK MFG., INC. |
| K922087 | ANTERIOR CERVICAL PLATE SYSTEM | Nov 06, 1992 | Substantially Equivalent | SOFAMOR DANEK MFG., INC. |
| K914362 | TOP CERVICAL SPINE PLATES & TITANIUM BONE SCREWS | Apr 29, 1992 | Substantially Equivalent | ACORN GROUP, INC. |
| K913730 | AESCULAP TITANIUM BONE PLATES | Mar 12, 1992 | Substantially Equivalent | AESCULAP, INC. |
| K910874 | THORACIC ANTERIOR SPINAL FIXATION PLATE | Feb 03, 1992 | Substantially Equivalent | TERRAY MANUFACTURING, INC. |
| K905023 | AMSET LOCKING PLATE SYSTEM | Jan 31, 1992 | Substantially Equivalent | ADVANCED MED/SURG, INC. |
| K901507 | MCAFFEE UNIVERSAL SPINAL SYSTEM (MUSS) | Jan 28, 1992 | Substantially Equivalent | KIRSCHNER MEDICAL CORP. |
| K910681 | SIMMONS PLATING SYSTEM | Oct 04, 1991 | Substantially Equivalent | SMITH & NEPHEW RICHARDS, INC. |
| K904446 | CASF (TM) (CONTOURED ANTERIOR SPINAL FIXATON SYS.) | Sep 05, 1991 | Substantially Equivalent | ACROMED CORP. |
| K873826 | ACROMED/KANEDA ANTERIOR SPINAL INSTRUMENTATION | Nov 30, 1988 | Substantially Equivalent | ACROMED CORP. |
| K853033 | HARTSHILL RECT & WIRES, SPINAL FIXATION SYSTEM | Sep 24, 1985 | Substantially Equivalent | A.W. SHOWELL (SURGICRAFT) LTD. |
| K851414 | SEGMENTAL SPINAL RODS | Jun 28, 1985 | Substantially Equivalent | STUART |
| K841189 | OEC/REZAIAN SPINAL FIXATOR | May 16, 1984 | Substantially Equivalent | ORTHOPEDIC EQUIPMENT CO., INC. |
| K831982 | BRADFORD SPINAL FRACTURE FIXATION SYS | Sep 20, 1983 | Substantially Equivalent | DEPUY, INC. |
| K820034 | ANTERIOR DISTRACTION SYSTEM | Mar 11, 1982 | Substantially Equivalent | STUART |
| K802222 | ANTERIOR KYPHOSIS DISTRACTION DEVICE | Oct 10, 1980 | Substantially Equivalent | ZIMMER, INC. |
| K792352 | SYNTHES CERVICAL VERTABRAE PLATES | Dec 06, 1979 | Substantially Equivalent | DEPUY SYNTHES |
| K790941 | D.T.T. LOCK SCREW INSERTER | May 23, 1979 | Substantially Equivalent | DEPUY, INC. |
| K790404 | DTT SYSTEM | Mar 21, 1979 | Substantially Equivalent | DEPUY, INC. |
| K782061 | SPINAL SURGERY INSTRUMENTATION | Mar 21, 1979 | Substantially Equivalent | STUART DRUG & SURGICAL SUPPLY, INC. |
FEI Numbers
This FDA classification entry is associated with 368 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 368 registration numbers. Click on an entry to view related FDA registrations.