Fastener, Fixation, Nondegradable, Soft Tissue
The nondegradable soft tissue fixation fastener is a permanent orthopedic implant used to anchor soft tissue structures such as ligaments or tendons to bone, remaining in place indefinitely after implantation. It is classified as FDA Class II under 21 CFR 888.3040 within the Orthopedic specialty, requiring 510(k) premarket clearance. The product code is MBI and it carries an implant flag. Full GMP quality system requirements apply and it does not sustain life.
Basic Information
- Product Code
- MBI
- Device Class
- FDA class 2
- Regulation Number
- 888.3040
- 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 565 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251145 | Arthrex PushLock Suture Anchors | Jul 10, 2025 | Substantially Equivalent | Arthrex Inc. |
| K251933 | SnugFit ASA Extension | Jul 01, 2025 | Substantially Equivalent | Medacta International S.A. |
| K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue) | Jun 25, 2025 | Substantially Equivalent | Smith & Nephew, Inc. |
| K251530 | CONMED Argo Knotless® Anchor | Jun 18, 2025 | Substantially Equivalent | CONMED Corporation |
| K250844 | PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP T; RIGIDLOOP Clip; RIGIDLOOP BTB; RIGIDLOOP Suture Loop | Jun 02, 2025 | Substantially Equivalent | Science & Bio Materials (S.B.M.) SAS |
| K242477 | Shoulder Soft Tissue Anchors | May 12, 2025 | Substantially Equivalent | Signature Orthopaedics Pty Ltd |
| K250596 | Arthrex FiberTak Suture Anchor | Mar 28, 2025 | Substantially Equivalent | Arthrex Inc. |
| K243988 | RootMend MRR | Mar 20, 2025 | Substantially Equivalent | Riverpoint Medical LLC |
| K250424 | Arthrex TightRope Soft Button, RT | Mar 11, 2025 | Substantially Equivalent | Arthrex Inc. |
| K250238 | WasherCap Fixation System | Feb 25, 2025 | Substantially Equivalent | ABANZA TECNOMED S.L |
| K244015 | SuperBall-RC | Feb 19, 2025 | Substantially Equivalent | Arcuro Medical Ltd. |
| K243665 | Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor) | Jan 31, 2025 | Substantially Equivalent | ZheJiang Decans Medical Devices Co., Ltd. |
| K243726 | Osprey Suture Anchor | Jan 30, 2025 | Substantially Equivalent | Responsive Arthroscopy, Inc. |
| K243712 | WasherCap Mini Fixation System (Model 45) | Jan 30, 2025 | Substantially Equivalent | ABANZA TECNOMED S.L. |
| K244025 | Argo Knotless GENESYS Anchor | Jan 28, 2025 | Substantially Equivalent | ConMed Corporation |
| K241234 | OTS 25-L (100-5) | Jan 23, 2025 | Substantially Equivalent | OTS Medical Ltd. |
| K242529 | Tigon Medical All-Suture Anchors (ASA) | Dec 20, 2024 | Substantially Equivalent | Tigon Medical |
| K243470 | Fix2Lock (PEEK Self Punching) | Dec 03, 2024 | Substantially Equivalent | Osteonic Co., Ltd. |
| K242494 | OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct | Nov 26, 2024 | Substantially Equivalent | Riverpoint Medical LLC |
| K243323 | Iconix Knotless Anchor | Nov 19, 2024 | Substantially Equivalent | Riverpoint Medical |
| K243203 | OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor | Oct 29, 2024 | Substantially Equivalent | Riverpoint Medical |
| K241695 | Extremity All Suture System | Sep 12, 2024 | Substantially Equivalent | Field Orthopaedics |
| K242296 | VersaTap Suture Anchor (ADP050); VersaPEEK Suture Anchor (APP002); MicroTi Suture Anchor (ATP003-M); VersaLat Ti Suture Anchor (ADP021-TI); VersaLat Suture Anchor (ADP021-PK) | Aug 29, 2024 | Substantially Equivalent | Ortho-Design (Pty) Ltd |
| K233601 | Fixone Meniscal Repair | Aug 02, 2024 | Substantially Equivalent | Aju Pharm Co., Ltd. |
| K241864 | Grappler Interference Screw System | Jul 25, 2024 | Substantially Equivalent | Paragon 28, Inc. |
| K240835 | Suture Button Repair System | Jul 19, 2024 | Substantially Equivalent | Skeletal Dynamics Inc |
| K241577 | Iconix® Anchor | Jul 03, 2024 | Substantially Equivalent | Riverpoint Medical |
| K241435 | Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blue | Jun 20, 2024 | Substantially Equivalent | Smith & Nephew, Inc. |
| K241235 | Arthrex TightRope II | May 29, 2024 | Substantially Equivalent | Arthrex, Inc. |
| K232941 | Megaloop Button System | May 03, 2024 | Substantially Equivalent | Suzhou Endophix Co., Ltd. |
| K240719 | OC JuggerKnot Soft Anchor | Apr 11, 2024 | Substantially Equivalent | Riverpoint Medical |
| K240594 | Grappler Suture Anchor R3FLEX IOL System | Mar 26, 2024 | Substantially Equivalent | Paragon 28, Inc. |
| K240407 | ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture Anchor | Mar 07, 2024 | Substantially Equivalent | Stryker Endoscopy |
| K240213 | Iconix Knotless Anchor | Feb 23, 2024 | Substantially Equivalent | Riverpoint Medical |
| K240194 | ProCinch, QuadCinch | Feb 21, 2024 | Substantially Equivalent | Riverpoint Medical |
| K233893 | AlphaVent Knotless SP PEEK Anchor | Jan 25, 2024 | Substantially Equivalent | Stryker Endoscopy |
| K233730 | Footprint Mini PK, 3.5mm Suture Anchor | Jan 17, 2024 | Substantially Equivalent | Smith & Nephew |
| K231033 | CEPTRE® Knotted UHMWPE Suture PEEK Anchor | Jan 04, 2024 | Substantially Equivalent | Healthium Medtech Limited |
| K230891 | SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair Implant | Dec 28, 2023 | Substantially Equivalent | Healthium Medtech Limited |
| K233659 | Suture Wing | Dec 26, 2023 | Substantially Equivalent | OSTEONIC Co., Ltd. |
| K233429 | OTS 25 (100-1) | Dec 07, 2023 | Substantially Equivalent | OTS Medical Ltd. |
| K233552 | IDEAL Ziploop | Nov 30, 2023 | Substantially Equivalent | Riverpoint Medical |
| K232973 | Arthrex Knee FiberTak® Button Suture Anchor | Nov 15, 2023 | Substantially Equivalent | Arthrex Inc |
| K233468 | Iconix Anchor | Nov 14, 2023 | Substantially Equivalent | Riverpoint Medical |
| K232886 | INFILOOP® Fixed Loop UHMWPE Suture Titanium Button | Nov 08, 2023 | Substantially Equivalent | Healthium Medtech Limited |
| K232742 | Arthrex FiberTak Suture Anchor | Nov 03, 2023 | Substantially Equivalent | Arthrex Inc. |
| K232725 | Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor | Nov 02, 2023 | Substantially Equivalent | Suzhou Endophix Co., Ltd. |
| K232683 | Knotilus+ PEEK Knotless Anchor | Oct 24, 2023 | Substantially Equivalent | Stryker Endoscopy |
| K233258 | Shadow Knotless All-Suture Anchors | Oct 23, 2023 | Substantially Equivalent | Responsive Arthroscopy LLC |
| K232492 | 2.7 mm GRYPHON Flex Knotless PEEK Anchor; 2.7 mm GRYPHON Flex Knotless Biocomposite Anchor | Oct 06, 2023 | Substantially Equivalent | Medos International SARL |
| K232411 | JuggerKnot Soft Anchor OC | Oct 06, 2023 | Substantially Equivalent | Riverpoint Medical, LLC |
| K231078 | All-Suture Anchor | Oct 05, 2023 | Substantially Equivalent | Riverpoint Medical, LLC |
| K232592 | CITRELOCK® DUO | Sep 20, 2023 | Substantially Equivalent | Acuitive Technologies, Inc. |
| K230517 | Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor) | Sep 11, 2023 | Substantially Equivalent | Jarmon Medical, LLC (DBA Legends Orthopedics) |
| K232457 | Q-FIX ULTRA All-Suture Anchor | Sep 08, 2023 | Substantially Equivalent | Smith & Nephew |
| K232340 | Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor | Sep 01, 2023 | Substantially Equivalent | Arthrex Inc. |
| K231093 | AlphaVent Suture Anchors | Aug 30, 2023 | Substantially Equivalent | Stryker Endoscopy |
| K230094 | Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors | Aug 25, 2023 | Substantially Equivalent | Responsive Arthroscopy LLC |
| K231867 | Grappler Suture Anchor System | Aug 21, 2023 | Substantially Equivalent | Paragon 28, Inc. |
| K231376 | Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape) | Aug 09, 2023 | Substantially Equivalent | Smith & Nephew Inc. |
| K231857 | Arthrex TightRope II | Aug 08, 2023 | Substantially Equivalent | Arthrex Inc. |
| K232005 | HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid) | Aug 04, 2023 | Substantially Equivalent | Smith & Nephew, Inc. |
| K231404 | T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button | Aug 04, 2023 | Substantially Equivalent | Healthium Medtech Limited |
| K223114 | Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors | Aug 02, 2023 | Substantially Equivalent | Gm Dos Reis Industria E Comerico Ltda |
| K231278 | Knotless Suture Anchor | Aug 01, 2023 | Substantially Equivalent | Riverpoint Medical, LLC |
| K231322 | Fix2Lock(PEEK Self Punching) | Jun 07, 2023 | Substantially Equivalent | Osteonic Co., Ltd. |
| K231002 | Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless) | Jun 07, 2023 | Substantially Equivalent | Suzhou Endophix Co., Ltd. |
| K231330 | FiberTak® Suture Anchor | Jun 01, 2023 | Substantially Equivalent | Arthrex Inc. |
| K230874 | Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath | May 23, 2023 | Substantially Equivalent | Suzhou Endophix Co., Ltd. |
| K223860 | Integrity Bone Staple Fixation System | May 22, 2023 | Substantially Equivalent | Anika Therapeutics Inc. |
| K231113 | Arthrex FiberTak Suture Anchor | May 18, 2023 | Substantially Equivalent | Arthrex Inc. |
| K231128 | JuggerKnot Soft Anchor | May 17, 2023 | Substantially Equivalent | Riverpoint Medical LLC |
| K230655 | PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw | May 03, 2023 | Substantially Equivalent | Signature Orthopaedics Pty Ltd |
| K230123 | Apollo Knotless Suture Anchor | May 03, 2023 | Substantially Equivalent | Maruho Medical |
| K230544 | SnugFit All-Suture Anchor extension | Apr 17, 2023 | Substantially Equivalent | Medacta International S.A. |
| K230568 | FiberTak Suture Anchor | Apr 01, 2023 | Substantially Equivalent | Arthrex Inc. |
| K222423 | Fixone All Suture Anchor | Mar 23, 2023 | Substantially Equivalent | AJU Pharm Co., Ltd. |
| K223889 | Stativ® Knotted UHMWPE Suture Anchor | Mar 22, 2023 | Substantially Equivalent | Healthium Medtech Limited |
| K220464 | Tigon Medical Gryphon Anchor Line | Mar 22, 2023 | Substantially Equivalent | Tigon Medical |
| K223878 | Aevumed RAPID Suture Anchors | Mar 17, 2023 | Substantially Equivalent | Aevumed, Inc. |
| K230433 | Arthrex Knotless FiberTak Suture Anchor | Mar 10, 2023 | Substantially Equivalent | Arthrex Inc. |
| K220966 | SINEFIX | Mar 08, 2023 | Substantially Equivalent | BAAT Medical Products B.V. |
| K223589 | Grappler Suture Anchor R3FLEX IOL System | Mar 03, 2023 | Substantially Equivalent | Paragon 28, Inc. |
| K223582 | MectaLock TI Triple Loaded Suture Anchor | Feb 24, 2023 | Substantially Equivalent | Medacta International S.A. |
| K230212 | OrthoButton AL | Feb 23, 2023 | Substantially Equivalent | Riverpoint Medical, LLC |
| K222971 | ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation Device | Feb 17, 2023 | Substantially Equivalent | Smith & Nephew Inc |
| K222574 | Simparo Anchor Line Fixation System | Feb 04, 2023 | Substantially Equivalent | Simparo, Inc. |
| K223284 | SutureLoc Implant | Feb 02, 2023 | Substantially Equivalent | Arthrex Inc. |
| K222589 | Flexible Suturing System with Anchors (FSSA) | Jan 26, 2023 | Substantially Equivalent | Integrity Orthopaedics, Inc. |
| K223795 | FairFix QT Adjustable Button | Jan 17, 2023 | Substantially Equivalent | Medacta International S.A. |
| K221396 | Arthrex FiberTak Suture Anchor | Dec 22, 2022 | Substantially Equivalent | Arthrex Inc. |
| K213110 | AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor | Dec 16, 2022 | Substantially Equivalent | Auxein Medical Private Limited |
| K222363 | Aevumed PHANTOM-LP Suture Anchors | Nov 28, 2022 | Substantially Equivalent | Aevumed, Inc. |
| K213018 | Auxilock GFS Mini, GFS II Large, and GFS Ultimate | Nov 18, 2022 | Substantially Equivalent | Auxein Medical Private Limited |
| K222763 | Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors | Oct 13, 2022 | Substantially Equivalent | Responsive Arthroscopy LLC |
| K212197 | WasherCap Fixation System | Sep 22, 2022 | Substantially Equivalent | Abanza Tecnomed SL. |
| K222091 | Grappler Suture Anchor System | Sep 14, 2022 | Substantially Equivalent | Paragon 28, Inc. |
| K221731 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire | Sep 07, 2022 | Substantially Equivalent | T.A.G. Medical Products Corporation, Ltd |
| K213109 | Auxilock Draw Tight Suture-Based Anchor | Aug 22, 2022 | Substantially Equivalent | Auxein Medical Private Limited |
| K222169 | FairFix Adjustable Button System | Aug 16, 2022 | Substantially Equivalent | Medacta International SA |
| K222161 | Arthrex Knotless FiberTak Biceps Suture Anchor | Aug 11, 2022 | Substantially Equivalent | Arthrex Inc. |
| K220901 | S-Core Implant System | Jul 29, 2022 | Substantially Equivalent | Subchondral Solutions, Inc. |
| K213104 | Auxilock Titanium Screw-In Suture Anchor | Jul 29, 2022 | Substantially Equivalent | Auxein Medical Private Limited |
| K221502 | Parcus Synd-EZ SS | Jul 26, 2022 | Substantially Equivalent | Parcus Medical, LLC |
| K221364 | Mitek TIGHT-N Anchor | Jul 11, 2022 | Substantially Equivalent | Medos International SARL |
| K221389 | FairFix AM Adjustable Button FairFix PSP Adjustable Button | Jun 08, 2022 | Substantially Equivalent | Medacta International S.A. |
| K221135 | X-Twist PEEK Suture Anchor | May 19, 2022 | Substantially Equivalent | Parcus Medical LLC |
| K220757 | Argo Knotless SP Anchor | May 13, 2022 | Substantially Equivalent | CONMED Corporation |
| K220797 | FootHold System | Apr 15, 2022 | Substantially Equivalent | CrossRoads Extremity Systems, LLC |
| K212381 | VersaTap, VersaLat, DueLock, VersaTi, MiniTi | Dec 06, 2021 | Substantially Equivalent | Ortho-Design (Pty) Ltd |
| K212739 | ActiFlip | Oct 06, 2021 | Substantially Equivalent | Parcus Medical LLC. |
| K211322 | Paratrooper Plantar Plate Repair System | Aug 30, 2021 | Substantially Equivalent | Paragon 28, Inc. |
| K211502 | Alpha Vent PEEK Suture Anchor | Aug 04, 2021 | Substantially Equivalent | Stryker Endoscopy |
| K211049 | Tigon Medical Button System | Aug 04, 2021 | Substantially Equivalent | Tigon Medical |
| K211002 | Grappler Suture Anchor System | Jul 07, 2021 | Substantially Equivalent | Paragon 28, Inc. |
| K202663 | Suture Wing | Jun 07, 2021 | Substantially Equivalent | Osteonic Co., Ltd. |
| K202763 | Fix2Lock (PEEK Self Punching) | Jun 04, 2021 | Substantially Equivalent | Osteonic Co., Ltd. |
| K203121 | Responsive Arthroscopy Thunderbolt System | Apr 27, 2021 | Substantially Equivalent | Responsive Arthroscopy LLC |
| K203259 | FairFix Adjustable Button System | Mar 26, 2021 | Substantially Equivalent | Medacta International SA |
| K210498 | Betta Link Knotless Implant System | Mar 24, 2021 | Substantially Equivalent | T.A.G. Medical Products Corporation, Ltd |
| K210078 | Stryker ProCinch Adjustable Loop Device | Mar 11, 2021 | Substantially Equivalent | Stryker Endoscopy |
| K202662 | Parcus Titanium Interference Screws | Feb 22, 2021 | Substantially Equivalent | Parcus Medical, LLC |
| K203740 | JuggerKnot Soft Anchor | Feb 12, 2021 | Substantially Equivalent | Riverpoint Medical |
| K203385 | TenoTac Soft Tissue Fixation System | Feb 11, 2021 | Substantially Equivalent | Paragon 28, Inc |
| K203794 | HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture | Feb 01, 2021 | Substantially Equivalent | Medos International Sarl |
| K203485 | SnugFit All-Suture Anchor | Jan 19, 2021 | Substantially Equivalent | Medacta International SA |
| K202291 | Button Loop | Jan 08, 2021 | Substantially Equivalent | Yunyi (Beijing) Medical Device Co., Ltd. |
| K192709 | Fixone All Suture Anchor | Dec 15, 2020 | Substantially Equivalent | AJU Pharm Co.,Ltd. |
| K203268 | Arthrex FiberTak Suture Anchor | Nov 27, 2020 | Substantially Equivalent | Arthrex Inc. |
| K202883 | Sterile bone screw (PEEK ACL screw) | Nov 25, 2020 | Substantially Equivalent | Osteonic Co., Ltd. |
| K193377 | TopLock Anchor System | Nov 25, 2020 | Substantially Equivalent | Fusion Orthopedics, LLC |
| K202444 | Knotless TensionTight Button Implant System | Nov 17, 2020 | Substantially Equivalent | Arthrex Inc. |
| K202355 | Stryker Omega PEEK Knotless Anchor System | Nov 13, 2020 | Substantially Equivalent | Stryker |
| K202178 | VersaLoop Anchor System | Nov 13, 2020 | Substantially Equivalent | T.A.G. Medical Products Corporation, Ltd |
| K200428 | Multi-Drive Interference Screw System | Nov 10, 2020 | Substantially Equivalent | Nvision Biomedical Technologies, Inc |
| K193214 | WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws | Nov 10, 2020 | Substantially Equivalent | Biomet Inc. |
| K202581 | Arthrex TightRope II | Nov 04, 2020 | Substantially Equivalent | Arthrex Inc. |
| K202259 | Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip | Oct 28, 2020 | Substantially Equivalent | Parcus Medical, LLC |
| K202193 | PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction | Oct 16, 2020 | Substantially Equivalent | S.B.M. SAS (Science & Bio Materials) |
| K192949 | Flower Suture Anchor Set | Oct 07, 2020 | Substantially Equivalent | Flower Orthopedics Corporation |
| K202399 | OrthoButton FL | Sep 18, 2020 | Substantially Equivalent | Riverpoint Medical |
| K202153 | Responsive Arthroscopy Suture Anchor System | Sep 09, 2020 | Substantially Equivalent | Responsive Arthroscopy LLC |
| K200503 | ATL Anchors | Sep 02, 2020 | Substantially Equivalent | International Life Sciences |
| K201636 | Hercules Suture Anchor System | Aug 20, 2020 | Substantially Equivalent | In2Bones USA, LLC |
| K201883 | 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor | Aug 07, 2020 | Substantially Equivalent | Medos International SARL |
| K201083 | Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors | Jul 23, 2020 | Substantially Equivalent | Parcus Medical, LLC |
| K200949 | HEALIX ADVANCE Anchor with DYNATAPE Suture | Jun 04, 2020 | Substantially Equivalent | Medos International SARL |
| K193108 | Bonecam Suture Anchor | Mar 26, 2020 | Substantially Equivalent | Valeris Medical Inc. |
| K200341 | Arthrex FiberTak Suture Anchor | Mar 12, 2020 | Substantially Equivalent | Arthrex Inc. |
| K192810 | Apollo Suture Anchor System | Mar 11, 2020 | Substantially Equivalent | Valeris Medical |
| K193402 | ALLthread PEEK Suture Anchor | Mar 05, 2020 | Substantially Equivalent | Biomet Inc. |
| K200028 | Coronet Soft Tissue Fixation System | Mar 04, 2020 | Substantially Equivalent | CoNextions Medical |
| K193245 | Dunamis PunchTac Suture Anchors | Feb 14, 2020 | Substantially Equivalent | Dunamis LLC |
| K193165 | MectaFix CL Fixation Button with Continuous Loop | Feb 10, 2020 | Substantially Equivalent | Medacta International SA |
| K193461 | MectaLock All-Suture Anchors | Feb 06, 2020 | Substantially Equivalent | Medacta International SA |
| K191677 | MectaTap TI Suture Anchor | Jan 29, 2020 | Substantially Equivalent | Medacta International SA |
| K191227 | Paratrooper Plantar Plate Repair System | Jan 24, 2020 | Substantially Equivalent | Paragon 28, Inc. |
| K193295 | Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor | Jan 23, 2020 | Substantially Equivalent | Parcus Medical, LLC |
| K193606 | Y-Knot OneStep Anchor | Jan 22, 2020 | Substantially Equivalent | ConMed Corporation |
| K192942 | ALLthread Titanium Suture Anchor | Jan 16, 2020 | Substantially Equivalent | Biomet Inc. |
| K192750 | AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip | Jan 16, 2020 | Substantially Equivalent | Parcus Medical, LLC |
| K193092 | TunneLoc Tibial Fixation Device | Jan 02, 2020 | Substantially Equivalent | Biomet Inc. |
| K191426 | FiberTak Button | Nov 26, 2019 | Substantially Equivalent | Arthrex Inc. |
| K192964 | Parcus Synd-EZ SS | Nov 22, 2019 | Substantially Equivalent | Parcus Medical, LLC |
| K191783 | Parcus Synd-EZ Ti | Oct 09, 2019 | Substantially Equivalent | Parcus Medical, LLC |
| K192428 | AFX Femoral Implant with Inserter | Oct 05, 2019 | Substantially Equivalent | Cayenne Medical |
| K191459 | JuggerStitch Meniscal Repair Device | Sep 13, 2019 | Substantially Equivalent | Biomet Inc. |
| K190288 | Arthrex Tenodesis Button | Sep 13, 2019 | Substantially Equivalent | Arthrex Inc. |
| K191300 | MectaLock Ti Suture Anchor | Sep 12, 2019 | Substantially Equivalent | Medacta International SA |
| K191319 | Dunamis Fixation Button System | Aug 29, 2019 | Substantially Equivalent | Dunamis LLC |
| K190774 | RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant | Jul 25, 2019 | Substantially Equivalent | Medos International SARL |
| K191053 | Xtreme-Loop | Jul 17, 2019 | Substantially Equivalent | Xiros Ltd |
| K191204 | Infinity Fixation System | Jul 03, 2019 | Substantially Equivalent | ConMed Corporation |
| K190915 | OsteoFab Suture Anchors | Jul 03, 2019 | Substantially Equivalent | Oxford Performance Materials, Inc. |
| K191483 | HEALIX ADVANCE Anchor with DYNA+TAPE Sutures | Jun 28, 2019 | Substantially Equivalent | Medos International SARL |
| K190892 | MectaScrew PEEK Interference Screw | Jun 04, 2019 | Substantially Equivalent | Medacta International SA |
| K190474 | MectaLock PEEK Suture Anchor | May 28, 2019 | Substantially Equivalent | Medacta International SA |
| K190125 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire | May 19, 2019 | Substantially Equivalent | T.A.G. Medical Products Corporation, Ltd |
| K190375 | Parcus ATLAS | Apr 24, 2019 | Substantially Equivalent | Parcus Medical, LLC |
| K190728 | Arthrex SwiveLock Anchors | Apr 17, 2019 | Substantially Equivalent | Arthrex Inc. |
| K190446 | Responsive Arthroscopy Wedge Push-In Suture Anchors | Mar 27, 2019 | Substantially Equivalent | Responsive Arthroscopy LLC |
| K190333 | Paradigm All-Suture Anchor 1.8mm, White/Black #2 | Mar 18, 2019 | Substantially Equivalent | ConMed Corporation |
| K183690 | Tenodesis Screw System | Mar 01, 2019 | Substantially Equivalent | Paragon 28,Inc. |
| K182941 | HEALIX ADVANCE SP PEEK Anchor | Feb 26, 2019 | Substantially Equivalent | Medos International SARL |
| K183279 | HEALIX Ti ANCHOR with DYNACORD | Feb 21, 2019 | Substantially Equivalent | Medos International SARL |
| K183331 | Parcus GFS BTB | Feb 07, 2019 | Substantially Equivalent | Parcus Medical, LLC |
| K182507 | Tigon Medical Tissue Anchors | Jan 21, 2019 | Substantially Equivalent | Tigon Medical |
| K181076 | Responsive Arthroscopy Wedge Push-In Suture Anchors | Jan 18, 2019 | Substantially Equivalent | Responsive Arthroscopy LLC |
| K182898 | TenoTac Soft Tissue Fixation System | Jan 14, 2019 | Substantially Equivalent | Paragon 28, Inc |
| K181086 | Cortical Fixation Systems | Jan 09, 2019 | Substantially Equivalent | Cousin Biotech S.A.S. |
| K182439 | TruShot with Y-Knot Shallow All-Suture Anchor | Jan 08, 2019 | Substantially Equivalent | ConMed Corporation |
| K182621 | CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver | Jan 04, 2019 | Substantially Equivalent | ConMed Corporation |
| K180951 | Responsive Arthroscopy Suture Anchor System | Jan 03, 2019 | Substantially Equivalent | Responsive Arthroscopy LLC |
| K182736 | OIC Suture Anchor System | Dec 28, 2018 | Substantially Equivalent | The Orthopaedic Implant Company |
| K181120 | 2.8 mm/3.3 mm PopLok Suture Anchors | Dec 21, 2018 | Substantially Equivalent | ConMed Corporation |
| K182446 | TruShot with Y-Knot All-Suture Anchor | Dec 19, 2018 | Substantially Equivalent | ConMed Corporation |
| K182264 | ICONN Revolution Knotless Suture Anchor | Oct 19, 2018 | Substantially Equivalent | ICONN Orthopedics, LLC |
| K181769 | Arthrex FiberTak Suture Anchor | Sep 21, 2018 | Substantially Equivalent | Arthrex, Inc. |
| K181513 | Arthrex PushLock Tenodesis Anchor | Aug 30, 2018 | Substantially Equivalent | Arthrex Inc. |
| K181680 | ICONN Answer II Suture Anchor | Aug 09, 2018 | Substantially Equivalent | ICONN Orthopedics, LLC |
| K180759 | SECULOK Suture Anchor | Aug 09, 2018 | Substantially Equivalent | U & I Corporation |
| K173845 | Arthrex SwiveLock | Aug 06, 2018 | Substantially Equivalent | Arthrex Inc. |
| K181083 | Stryker All-PEEK Knotless Anchor System | Jul 23, 2018 | Substantially Equivalent | Stryker |
| K180464 | AEVUMED PHANTOM Suture Anchors | May 31, 2018 | Substantially Equivalent | Aevumed, Inc. |
| K173269 | KATOR Suture Anchor | May 30, 2018 | Substantially Equivalent | KATOR LLC |
| K173074 | ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor | Apr 04, 2018 | Substantially Equivalent | Stryker |
| K180274 | Ventix Link Knotless Anchor with Inserter | Mar 21, 2018 | Substantially Equivalent | Cayenne Medical, Inc |
| K180118 | Arthrex NanoSuture Anchor | Feb 12, 2018 | Substantially Equivalent | Arthrex Inc. |
| K173278 | ToggleLoc System | Jan 05, 2018 | Substantially Equivalent | Biomet Inc. |
| K172491 | ICONN Square 2.5MM Suture Anchor | Nov 29, 2017 | Substantially Equivalent | ICONN Orthopedics, LLC |
| K172921 | Stryker Self-Punching ICONIX | Nov 20, 2017 | Substantially Equivalent | Stryker |
| K171640 | M-ARS ACL: Anatomic Ribbon Surgery System | Oct 23, 2017 | Substantially Equivalent | Medacta International SA |
| K172186 | BioWick X Implant with Driver | Oct 16, 2017 | Substantially Equivalent | Cayenne Medical, Inc. |
| K172612 | FiberTak DX | Sep 28, 2017 | Substantially Equivalent | Arthex, Inc |
| K171964 | LigaMetrics Suture Anchors | Sep 19, 2017 | Substantially Equivalent | Mortise Medical LLC |
| K171725 | CuffLink Implant System | Sep 08, 2017 | Substantially Equivalent | CONMED Corporation |
| K171465 | Stryker Self-Punching ICONIX | Aug 24, 2017 | Substantially Equivalent | Stryker |
| K172165 | Q-Fix Suture Anchor | Aug 17, 2017 | Substantially Equivalent | ArthroCare Corporation |
| K170388 | ANCHORMAN Tibial Ligament Fixation Device | Jul 25, 2017 | Substantially Equivalent | Summit Medical Ltd. |
| K171060 | OrthoButton AL | Jun 02, 2017 | Substantially Equivalent | Riverpoint Medical |
| K170877 | Parcus SLiK Fix Screw | Jun 02, 2017 | Substantially Equivalent | Parcus Medical |
| K171020 | Arthrex Knotless SutureTak Anchor | May 16, 2017 | Substantially Equivalent | Arthrex Inc. |
| K170098 | ICONIX TT All Suture Anchor | Mar 31, 2017 | Substantially Equivalent | Stryker |
| K170327 | Parcus SLiK Anchors | Mar 30, 2017 | Substantially Equivalent | Parcus Medical |
| K170265 | GRAVITYTM PEEK-OPTIMA Suture Anchor | Feb 23, 2017 | Substantially Equivalent | Wright Medical Technology, Inc. |
| K163258 | CrossFT Knotless Suture Anchor with Disposable Driver | Jan 25, 2017 | Substantially Equivalent | ConMed Corporation |
| K163034 | SUTUREFIX Curved Suture Anchor | Dec 07, 2016 | Substantially Equivalent | Smith and Nephew, Inc. |
| K162198 | GFS Ultimate | Nov 18, 2016 | Substantially Equivalent | PARCUS MEDICAL, LLC |
| K162386 | KATOR Suture Anchor | Oct 25, 2016 | Substantially Equivalent | KATOR LLC |
| K161033 | AFX Femoral Implant With Inserter | Aug 03, 2016 | Substantially Equivalent | CAYENNE MEDICAL, INC. |
| K160996 | Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm | Jul 06, 2016 | Substantially Equivalent | Dunamis LLC |
| K161001 | MILAGRO ADVANCE PEEK Interference Screw | Jun 09, 2016 | Substantially Equivalent | MEDOS INTERNATIONAL SARL |
| K160655 | OrthoButton CL | Jun 03, 2016 | Substantially Equivalent | RIVERPOINT MEDICAL |
| K160319 | FiberTak DR | May 10, 2016 | Substantially Equivalent | ARTHREX, INC. |
| K153585 | Flip Button Suture Anchor | May 05, 2016 | Substantially Equivalent | FIRST RAY LLC |
| K160118 | STROPP (Single Tunnel Repair of Plantar Plate) | May 03, 2016 | Substantially Equivalent | CROSSROADS EXTREMITY SYSTEMS, LLC |
| K153558 | Ventix Suture Anchor | Apr 21, 2016 | Substantially Equivalent | BIOMET MANUFACTURING CORP. |
| K160500 | Elite SPK, Compasso, Elite SPK Kit | Apr 20, 2016 | Substantially Equivalent | NCS Lab Srl |
| K153667 | TRUESPAN Meniscal Repair System | Mar 24, 2016 | Substantially Equivalent | Medos International SARL |
| K152262 | Ventix Knotless Anchors | Mar 08, 2016 | Substantially Equivalent | BIOMET MANUFACTURING CORP. |
| K151092 | Arthrex Short Suture Anchors | Feb 23, 2016 | Substantially Equivalent | Arthrex, Inc. |
| K153186 | Adjustable Fixation Device | Jan 28, 2016 | Substantially Equivalent | ARTHROCARE CORP. |
| K153669 | MultiFIX S Ultra Knotless Fixation System | Jan 19, 2016 | Substantially Equivalent | ArthoCare Corporation |
| K153313 | SpeedLock Knotless Fixation System | Dec 11, 2015 | Substantially Equivalent | ARTHROCARE CORPORATION |
| K152566 | PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor, HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors | Dec 02, 2015 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K152711 | Parcus GFS Naked | Nov 20, 2015 | Substantially Equivalent | PARCUS MEDICAL, LLC |
| K151004 | PULLUP® Adjustable Juxtacortical Fixation Device | Nov 17, 2015 | Substantially Equivalent | SBM SCIENCES FOR BIO MATERIALS |
| K152255 | BoneCam Suture Anchors | Nov 16, 2015 | Substantially Equivalent | VALERIS MEDICAL |
| K152236 | KATOR Suture Anchor | Nov 04, 2015 | Substantially Equivalent | KATOR LLC |
| K151220 | Dunamis Interference Screw | Oct 14, 2015 | Substantially Equivalent | Dunamis LLC |
| K151601 | SECURE-LOOP | Sep 09, 2015 | Substantially Equivalent | XIROS LTD |
| K150768 | JuggerKnot Soft Anchors | Sep 04, 2015 | Substantially Equivalent | BIOMET MANUFACTURING CORP. |
| K150648 | Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm | Aug 20, 2015 | Substantially Equivalent | ARTHREX, INC. |
| K151897 | MultiFIX® P Knotless Fixation Device | Aug 06, 2015 | Substantially Equivalent | ArthroCare Corporation |
| K150715 | 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors | Jul 28, 2015 | Substantially Equivalent | TORNIER, INC. |
| K151068 | SureLock W Suture Anchor | Jul 24, 2015 | Substantially Equivalent | CAYENNE MEDICAL, INC |
| K151314 | CinchLock Flex Knotless Suture Anchor | Jul 23, 2015 | Substantially Equivalent | Pivot Medical |
| K151660 | MultiFIX S Knotless Fixation System | Jul 16, 2015 | Substantially Equivalent | ArthroCare Corporation |
| K151037 | GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle | Jul 09, 2015 | Substantially Equivalent | CONMED CORPORATION |
| K143745 | Arthrex Corkscrew and SwiveLock Suture Anchors | Jul 02, 2015 | Substantially Equivalent | Arthrex, Inc. |
| K151201 | Stryker ICONIX with Needles | Jun 29, 2015 | Substantially Equivalent | Stryker |
| K151230 | Arthrex FiberTak Anchors | Jun 19, 2015 | Substantially Equivalent | Arthrex, Inc. |
| K150424 | JuggerStitch Meniscal Repair Device | May 15, 2015 | Substantially Equivalent | BIOMET MANUFACTURING CORP. |
| K143473 | Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock All-Suture Anchor, 1.4mm with (1) size 2-0 UHMWPE suture with needles | Mar 25, 2015 | Substantially Equivalent | CAYENNE MEDICAL, INC |
| K150166 | Extremity Medical Suture Anchor | Feb 23, 2015 | Substantially Equivalent | EXTREMITY MEDICAL LLC |
| K143392 | Quattro Bolt Tenodesis Screw | Jan 23, 2015 | Substantially Equivalent | CAYENNE MEDICAL, INC |
| K142643 | Stabilynx PEEK Suture Anchor | Dec 15, 2014 | Substantially Equivalent | D3 DC, LLC /Stabilynx, Inc |
| K142574 | 4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, | Oct 24, 2014 | Substantially Equivalent | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K142653 | G-Lok and G-Lok XL Extender | Oct 16, 2014 | Substantially Equivalent | T.A.G. Medical Products Corporation, Ltd |
| K142230 | Apollo Suture Anchor System and Titan Screws | Sep 10, 2014 | Substantially Equivalent | Valeris Medical |
| K140476 | ARTHREX FIBERTAK SUTURE ANCHOR | Aug 13, 2014 | Substantially Equivalent | ARTHREX, INC. |
| K141011 | G-FORCE GEN 2 SUTURE ANCHOR SYSTEM | Jul 30, 2014 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K141711 | PONTIS 3MM SUTURE ANCHORS WITH ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE SUTURE, PONTIS ULTRA-HIGH MOLECULAR WEIGHT POLYE | Jul 24, 2014 | Substantially Equivalent | PONTIS ORTHOPAEEICS, LLC |
| K140879 | BIOSURE HEALICOIL PK INTERFERENCE SCREW | Jul 21, 2014 | Substantially Equivalent | Smith & Nephew, Inc |
| K140324 | RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL | Jul 07, 2014 | Substantially Equivalent | DEPUY MITEK, A JOHNSON AND JOHNSON COMPANY |
| K133579 | MULTIFILAMENT STAINLESS STEEL SUTURES WITH CRIMPS | Jun 26, 2014 | Substantially Equivalent | PONTIS ORTHOPAEDICS, LLC |
| K140925 | ACUMED SUTURE ANCHOR SYSTEM | May 20, 2014 | Substantially Equivalent | ACUMED, LLC |
| K140604 | MULTIFIX S KNOTLESS FIXATION SYSTEM | May 14, 2014 | Substantially Equivalent | ARTHROCARE CORPORATION |
| K132724 | ICONN ANSWER SUTURE ANCHOR | Apr 17, 2014 | Substantially Equivalent | ICONN ORTHOPEDICS, LLC |
| K133235 | THREADED PEEK K-WIRE | Apr 07, 2014 | Substantially Equivalent | MTP SOLUTIONS LLC |
| K133777 | TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR | Apr 04, 2014 | Substantially Equivalent | TORNIER, INC. |
| K133606 | N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE ACL TIBIAL IMPLANT, VARIOUS CLASS I ANCILL | Apr 01, 2014 | Substantially Equivalent | ARTHROCARE CORPORATION |
| K133469 | ACUMED SUTURE ANCHOR SYSTEM | Mar 10, 2014 | Substantially Equivalent | ACUMED, LLC |
| K133036 | APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS | Mar 06, 2014 | Substantially Equivalent | AMENDIA INC. |
| K133671 | ICONIX ALL SUTURE ANCHORS | Feb 28, 2014 | Substantially Equivalent | STRYKER CORP. |
| K133757 | GFS II STANDARD, GFS II LARGE, GFS MIMI | Feb 04, 2014 | Substantially Equivalent | PARCUS MEDICAL, LLC |
| K133229 | TITANIUM SUTURE ANCHOR | Jan 30, 2014 | Substantially Equivalent | MTP SOLUTIONS LLC |
| K133727 | Q-FIX SUTURE ANCHOR, 1.8MM; Q-FIX SUTURE ANCHOR, 2.8MM; DRILL, DRILL GUIDE AND OBTURATOR, 1.8MM & 2.8MM, FIRSTPASS SUTU | Jan 16, 2014 | Substantially Equivalent | ARTHROCARE CORPORATION |
| K133224 | Y-KNOT RC ALL-SUTURE ANCHOR, 2.8MM - DOUBLE LOADED AND TRIPLE LOADED W/ #2 HIFI SUTURES | Jan 03, 2014 | Substantially Equivalent | CONMED CORPORATION |
| K132867 | SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 2.2MM | Dec 30, 2013 | Substantially Equivalent | CAYENNE MEDICAL, INC. |
| K132783 | EXOSHAPE DUO SOFT TISSUE FASTENER | Dec 09, 2013 | Substantially Equivalent | MEDSHAPE, INC |
| K130467 | POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTURE | Dec 05, 2013 | Substantially Equivalent | MEDSHAPE, INC |
| K122437 | NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS | Oct 18, 2013 | Substantially Equivalent | BIOMET SPORTS MEDICINE |
| K132461 | A.I.M. SUTURE ANCHOR | Oct 16, 2013 | Substantially Equivalent | ANCHOR INNOVATION MEDICAL, INC. |
| K131769 | CINCHLOCK KNOTLESS SUTURE ANCHOR, NANOTACK SUTURE ANCHOR 1.4MM | Oct 07, 2013 | Substantially Equivalent | PIVOT MEDICAL INC. |
| K132632 | TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES | Sep 19, 2013 | Substantially Equivalent | TORNIER, INC. |
| K132513 | Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM AND KNOT PUSHER | Sep 19, 2013 | Substantially Equivalent | ARTHROCARE CORPORATION |
| K132590 | 5.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, 6.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, INSERTION GUIDE WITH OBTURATOR, TA | Sep 17, 2013 | Substantially Equivalent | ARTHROCARE CORPORATION |
| K131635 | ROTATION MEDICAL BONE STAPLE (RMB STAPLE) | Aug 29, 2013 | Substantially Equivalent | ROTATION MEDICAL, INC. |
| K131325 | QUATTRO GL SUTURE ANCHOR | Aug 16, 2013 | Substantially Equivalent | CAYENNE MEDICAL, INC. |
| K130814 | RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM | Aug 01, 2013 | Substantially Equivalent | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K130033 | TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TO | Aug 01, 2013 | Substantially Equivalent | BIOMET MANUFACTURING CORP. |
| K131182 | MULTIFIX S KNOTLESS FIXATION DEVICE | Jul 29, 2013 | Substantially Equivalent | ARTHOCARE CORPORATION |
| K131035 | Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM | Jul 02, 2013 | Substantially Equivalent | LINVATEC CORPORATION D/B/A CONMED LINVATEC |
| K131683 | HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM) | Jun 27, 2013 | Substantially Equivalent | DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY |
| K130217 | ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM | Jun 20, 2013 | Substantially Equivalent | ORTHOPEDIATRICS, CORP. |
| K130539 | HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM) | May 21, 2013 | Substantially Equivalent | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K130458 | KNOTLESS FIBERTAK SUTURE ANCHOR | May 03, 2013 | Substantially Equivalent | ARTHREX, INC. |
| K123485 | JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF | Mar 18, 2013 | Substantially Equivalent | BIOMET SPORTS MEDICINE |
| K122059 | ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS | Mar 18, 2013 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K130351 | NANOTACK SUTURE ANCHOR 1.4MM WITH FLEX INSERTER | Mar 14, 2013 | Substantially Equivalent | PIVOT MEDICAL INC. |
| K123350 | ECLIPSE SOFT TISSUE FASTENER | Mar 07, 2013 | Substantially Equivalent | MEDSHAPE, INC |
| K120740 | COLS® FIXATION SYSTEM | Mar 05, 2013 | Substantially Equivalent | FOURNITURES HOSPITALIERES INDUSTRIE |
| K130196 | SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR | Feb 27, 2013 | Substantially Equivalent | ARTHROCARE CORP. |
| K123651 | CINCHLOCK KNOTLESS SUTURE ANCHOR | Feb 21, 2013 | Substantially Equivalent | PIVOT MEDICAL |
| K123425 | TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL | Feb 20, 2013 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K123240 | SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT | Feb 14, 2013 | Substantially Equivalent | ARTHROCARE CORPORATION |
| K122805 | PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR | Feb 05, 2013 | Substantially Equivalent | PARCUS MEDICAL, LLC |
| K123579 | FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL | Jan 23, 2013 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K122336 | Q-FIX SUTURE ANCHOR, 1.8MM Q-FIX ACCESS TOOLS (DRILL GUIDE W/OBTURATOR, DRILL BIT) 1.8MM | Jan 09, 2013 | Substantially Equivalent | ELEVEN BLADE SOLUTIONS, INC. |
| K123341 | ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON, ARTHREX PROXIMAL BICEPS BUTTON | Dec 21, 2012 | Substantially Equivalent | ARTHREX, INC. |
| K122954 | CINCHER-2.6 SUTURE ANCHOR MODEL FG-001 | Dec 19, 2012 | Substantially Equivalent | FOUNDRY NEWCO XI, INC. |
| K120356 | NCS FISH-FIT MD SYSTEM FISH-FIT MD COMPASS MD | Dec 11, 2012 | Substantially Equivalent | NCS LAB SRL |
| K121356 | MICRO/MINI N-PK(H) BONE ANCHOR | Nov 09, 2012 | Substantially Equivalent | ANULEX TECHNOLOGIES, INC |
| K121354 | MICRO/MINI N-PK(F) BONE ANCHOR | Nov 09, 2012 | Substantially Equivalent | ANULEX TECHNOLOGIES, INC |
| K122314 | QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY | Oct 31, 2012 | Substantially Equivalent | CAYENNE MEDICAL, INC. |
| K122463 | APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W | Oct 11, 2012 | Substantially Equivalent | CAYENNE MEDICAL, INC. |
| K122123 | 6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED | Oct 02, 2012 | Substantially Equivalent | DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY |
| K120943 | SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT SPEEDLOCK HIP DRILL SPEEDLOCK HIP GUIDE CROWN TIP SPEEDLOCK HIP PATHFINDER | Sep 21, 2012 | Substantially Equivalent | ARTHROCARE CORPORATION |
| K120509 | STRYKER ALL SUTURE ANCHORS | Jul 26, 2012 | Substantially Equivalent | Stryker |
| K120824 | 3.9MM REELX STT SUTURE ANCHOR SYSTEM | Jul 18, 2012 | Substantially Equivalent | STRYKER CORP. |
| K121018 | BIORAPTOR 2.9, BIORAPTOR 2.3 PK, OSTEORAPTOR, & BIORAPTOR KNOTLESS SUTURE AN | Jun 22, 2012 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K120841 | APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHOR | Jun 07, 2012 | Substantially Equivalent | KFX MEDICAL |
| K120942 | PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR & PARCUS TRIPLE TWIST 5.5MM PEEK SUTURE ANC | Apr 20, 2012 | Substantially Equivalent | PARCUS MEDICAL, LLC |
| K120096 | MULTIFIX P KNOTLESS FIXATION DEVICE | Mar 27, 2012 | Substantially Equivalent | ARTHROCARE CORPORATION |
| K113274 | FOOTPRINT ULTRA PK SUTURE ANCHOR | Mar 06, 2012 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K113297 | KNOTILUS ANCHOR SYSTEM | Mar 02, 2012 | Substantially Equivalent | T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. |
| K120155 | ARTHREX KNOTLESS SUTURETAK ANCHOR | Feb 17, 2012 | Substantially Equivalent | ARTHREX, INC. |
| K112526 | TWINFIX ULTRA TI, TWINFIX ULTRA PK, TWINFIX ULTRA HA SUTURE ANCHORS | Jan 31, 2012 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K113294 | SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR | Jan 20, 2012 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K113730 | PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS | Jan 17, 2012 | Substantially Equivalent | PARCUS MEDICAL, LLC |
| K112814 | CUFFINK | Jan 17, 2012 | Substantially Equivalent | CAYENNE MEDICAL, INC. |
| K112417 | VARIOUS | Jan 13, 2012 | Substantially Equivalent | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K112960 | LABRALINK SUTURE ANCHOR WITH INSERTER, 2.9MM PER-LOADED WITH ONE (1) AND (2) #2 UHMWPE SUTURE | Jan 09, 2012 | Substantially Equivalent | CAYENNE MEDICAL, INC. |
| K113299 | ROG SUTURE ANCHOR | Dec 15, 2011 | Substantially Equivalent | ROG SPORTS MEDICINE, INC. |
| K112876 | CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5 | Dec 15, 2011 | Substantially Equivalent | CAYENNE MEDICAL, INC. |
| K112991 | MODIFIED ROG SUTURE ANCHOR | Dec 08, 2011 | Substantially Equivalent | ROG SPORTS MEDICINE, INC. |
| K112296 | LATERAL BUTTON | Dec 01, 2011 | Substantially Equivalent | T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. |
| K111716 | KNOTLESS SUTURE FIXATION SYSTEM | Nov 10, 2011 | Substantially Equivalent | CORE ESSENCE ORTHOPAEDICS |
| K112965 | NANO SUTURE ANCHOR | Nov 02, 2011 | Substantially Equivalent | LINVATEC CORPORATION D/B/A CONMED LINVATEC |
| K110800 | META-LOCK SUTURE ANCHOR SYSTEM | Sep 27, 2011 | Substantially Equivalent | TARSUS MEDICAL INC. |
| K111661 | ARTHREX SCAPHOLUNATE ANCHOR | Aug 19, 2011 | Substantially Equivalent | ARTHREX, INC. |
| K110879 | BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR | Aug 19, 2011 | Substantially Equivalent | BIOMET SPORTS MEDICINE |
| K111044 | SPEEDLOCK KNOTLESS FIXATION DEVICE; 3.0MM DRILL; SHARP TIPPED OBTURATOR; LOW PROFILE DRILL GUIDDE | Aug 09, 2011 | Substantially Equivalent | ARTHROCARE CORPORATION |
| K111779 | Y-KNOT ALL-SUTURE ANCHOR MODEL HF13 | Aug 08, 2011 | Substantially Equivalent | CONMED LINVATEC |
| K111590 | ROG SUTURE ANCHOR, ROG KNOTLESS SUTURE ANCHOR | Aug 08, 2011 | Substantially Equivalent | ROG SPORTS MEDICINE, INC. |
| K111631 | GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN.. | Jul 22, 2011 | Substantially Equivalent | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K111399 | SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75 | Jul 20, 2011 | Substantially Equivalent | ARTHROCARE CORP. |
| K111397 | TITAN TI SUTURE ANCHOR SYSTEM | Jul 12, 2011 | Substantially Equivalent | ARTHROCARE CORP. |
| K110545 | SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK) | Jun 24, 2011 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K111564 | MAXFIRE MARXMEN MENISCAL REPAIR DEVICE | Jun 16, 2011 | Substantially Equivalent | BIOMET SPORTS MEDICINE |
| K111471 | EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE) | Jun 10, 2011 | Substantially Equivalent | MEDSHAPE SOLUTIONS, INC |
| K110773 | TORNIER INSITE FT SUTURE ANCHOR | Jun 02, 2011 | Substantially Equivalent | TORNIER, INC. |
| K110781 | 5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTRACTION TOOL, 5.5 / 6.5MM PUNCH TAP | May 27, 2011 | Substantially Equivalent | ARTHROCARE CORP. |
| K110473 | NANOTACK SUTURE ANCHOR 1.4MM | May 25, 2011 | Substantially Equivalent | PIVOT MEDICAL |
| K110230 | ROG KNOTLESS SUTURE ANCHOR | May 19, 2011 | Substantially Equivalent | ROG SPORTS MEDICINE, INC. |
| K110229 | ROG SUTURE ANCHOR 5.5MM, 2.9MM | May 18, 2011 | Substantially Equivalent | ROG SPORTS MEDICINE, INC. |
| K103262 | QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM | Apr 05, 2011 | Substantially Equivalent | TORNIER, INC. |
| K110145 | BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHOR | Mar 04, 2011 | Substantially Equivalent | BIOMET, INC. |
| K102539 | ICUFF REPAIR PLATE, RIGHT; CUFF REPAIR PLATE. LEFT; ANCHOR BOLT, 10MM THROUGH 50MM | Feb 24, 2011 | Substantially Equivalent | SHOULDER OPTIONS, INC. |
| K103145 | HAMMERLOC TM TIBIAL FIXATION DEVICE | Feb 09, 2011 | Substantially Equivalent | BIOMET SPORTS MEDICINE |
| K110164 | 5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL | Feb 07, 2011 | Substantially Equivalent | ARTHROCARE CORP. |
| K101616 | THE GRAPPLR AND GRAPPLR EXTENDER | Jan 06, 2011 | Substantially Equivalent | TAG MEDICAL CORP. |
| K103060 | ARTHREX TIBIAL GRAFTBOLT | Jan 05, 2011 | Substantially Equivalent | ARTHREX, INC. |
| K102660 | BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS | Dec 13, 2010 | Substantially Equivalent | SMITH & NEPHEW ENDOSCOPY, INC. |
| K101126 | PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS | Dec 02, 2010 | Substantially Equivalent | CORE ESSENCE ORTHOPAEDICS, INC. |
| K101437 | SPEEDFIX SUTURE SYSTEM | Oct 29, 2010 | Substantially Equivalent | ARTHROCARE CORP. |
| K102262 | ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM; PUNCH TAP ; EXTRACTION TOOL | Oct 21, 2010 | Substantially Equivalent | ARTHROCARE CORP. |
| K102443 | INTRAFIX TIBIAL SHEATH | Oct 20, 2010 | Substantially Equivalent | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K101063 | SLEEVE WITH ZIPLOOP FIXATION DEVICES | Jun 23, 2010 | Substantially Equivalent | BIOMET SPORTS MEDICINE |
| K101448 | OPUS SPEEDSCREW SYSTEM | Jun 21, 2010 | Substantially Equivalent | ARTHROCARE CORP. |
| K100630 | G-FORCE PEEK SUTURE ANCHOR SYSTEM | Jun 11, 2010 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K101175 | KFX APPIANFX PEEK FEMORAL IMPLANT WITH INSERTER | May 20, 2010 | Substantially Equivalent | KFX MEDICAL |
| K101184 | TITAN TI SUTURE ANCHOR SYSTEM, MODELS 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022, 22-9005,, 22-9006 | May 18, 2010 | Substantially Equivalent | ARTHROCARE CORP. |
| K100159 | SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR | Apr 19, 2010 | Substantially Equivalent | SMITH & NEPHEW INC., ENDOSCOPY DIV. |
| K093935 | SMITH & NEPHEW FOOTPRINT RCX PK SUTURE ANCHOR | Apr 05, 2010 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K100579 | G-FORCE TI SUTURE ANCHOR SYSTEM | Mar 26, 2010 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K093912 | ARTHREX TIBIAL GRAFTBOLT | Mar 18, 2010 | Substantially Equivalent | ARTHREX, INC. |
| K093943 | BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM | Mar 05, 2010 | Substantially Equivalent | SMITH & NEPHEW INC., ENDOSCOPY DIV. |
| K093897 | SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR | Mar 04, 2010 | Substantially Equivalent | SMITH & NEPHEW INC., ENDOSCOPY DIV. |
| K092836 | OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE, MODEL 228140, RAPIDLOC A2 MENISCAL REPAIR SYSTEM/12 DEGREE, MODEL 228141 | Feb 04, 2010 | Substantially Equivalent | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K092998 | CONMED LINVATEC INTERCEPT IMPLANT | Dec 23, 2009 | Substantially Equivalent | LINVATEC CORP. |
| K093428 | SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR | Dec 17, 2009 | Substantially Equivalent | SMITH & NEPHEW ENDOSCOPY, INC. |
| K093228 | SMITH & NEPHEW TWINFIX ULTRA PK SUTURE ANCHOR | Dec 15, 2009 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K092914 | WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES | Dec 09, 2009 | Substantially Equivalent | MEDSHAPE SOLUTIONS |
| K091094 | PARCUS V-LOX PEEK CF SUTURE ANCHOR, MODELS: 10253, 10254, 10263, 10264 | Sep 30, 2009 | Substantially Equivalent | PARCUS MEDICAL, LLC |
| K091870 | TORNIER, PITON FIXATION IMPLANT SYSTEM | Sep 21, 2009 | Substantially Equivalent | TORNIER |
| K090923 | PARCUS GRAFT FIXATION SYSTEM | Jun 30, 2009 | Substantially Equivalent | PARCUS MEDICAL, LLC |
| K091549 | CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM | Jun 23, 2009 | Substantially Equivalent | LINVATEC CORP. |
| K091503 | MAGNUM MP FIXATION DEVICE | Jun 17, 2009 | Substantially Equivalent | ARTHROCARE CORP. |
| K090615 | OPUS SPEEDLOCK KNOTLESS FIXATION DEVICE | Jun 03, 2009 | Substantially Equivalent | ARTHROCARE CORP. |
| K090530 | SPIN-LOC SUTURE ANCHOR SYSTEM FG-0302-01,FG-0305-01 | May 20, 2009 | Substantially Equivalent | ROSS CREEK MEDICAL INC. |
| K090380 | MAGNUM M FIXATION DEVICE | Mar 13, 2009 | Substantially Equivalent | ARTHROCARE CORP. |
| K090075 | PARCUS V-LOX TITANIUM SUTURE ANCHOR,MODELS: 10251, 10252, 10257, 10258 | Mar 06, 2009 | Substantially Equivalent | PARCUS MEDICAL, LLC |
| K083609 | KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE | Mar 06, 2009 | Substantially Equivalent | KFX MEDICAL |
| K083635 | SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW | Jan 30, 2009 | Substantially Equivalent | SMITH & NEPHEW ENDOSCOPY, INC. |
| K083226 | SMITH & NEPHEW PEEK INTERFERENCE SCREW | Jan 30, 2009 | Substantially Equivalent | SMITH & NEPHEW ENDOSCOPY, INC. |
| K083151 | EXTREMITY MEDICAL SUTURE ANCHOR | Jan 22, 2009 | Substantially Equivalent | EXTREMITY MEDICAL LLC |
| K083150 | G-FORCE TENODESIS SCREW | Jan 15, 2009 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K083240 | OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES | Jan 12, 2009 | Substantially Equivalent | ARTHROCARE CORP. |
| K082729 | RIMCLOSE BONE ANCHOR | Dec 19, 2008 | Substantially Equivalent | ANULEX TECHNOLOGIES, INC |
| K083070 | TOGGLELOC SYSTEM | Dec 16, 2008 | Substantially Equivalent | BIOMET SPORTS MEDICINE |
| K081348 | TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD | Oct 17, 2008 | Substantially Equivalent | TRIMED, INC. |
| K081511 | 2.0 PK SUTURE ANCHOR T, 2.0 PK SUTURE ANCHOR S | Aug 26, 2008 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K081497 | OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS FIXATION DEVICE (MODEL OM-1503) | Jul 28, 2008 | Substantially Equivalent | ARTHROCARE CORP. |
| K081598 | SUTURE LOCK NAIL BONE ANCHOR WITH WHITE (KFX-W-200) & BLUE (KFX-B-200) FIBERFORCE SUTURE | Jul 03, 2008 | Substantially Equivalent | KFX MEDICAL |
| K080447 | SURGICRAFT SCREW FIXATION SYSTEM | Jun 13, 2008 | Substantially Equivalent | SURGICRAFT LTD. |
| K080335 | TORNIER CINCH KNOTLESS FIXATION IMPLANT SYSTEM | Apr 23, 2008 | Substantially Equivalent | TORNIER, INC. |
| K080229 | 5.5 MM SUTURE LOCK BONE SCREW ANCHOR | Feb 29, 2008 | Substantially Equivalent | KFX MEDICAL |
| K073481 | THREVO ANCHOR, DISPOSABLE DRIVER, HI-FI SUTURES | Jan 07, 2008 | Substantially Equivalent | CONMED LINVATEC |
| K073226 | CINCH KNOTLESS FIXATION IMPLANT SYSTEM | Dec 07, 2007 | Substantially Equivalent | C2M MEDICAL, INC. |
| K072063 | KFX TISSUE FIXATION SYSTEM AND ACCESSORIES | Oct 26, 2007 | Substantially Equivalent | KFX MEDICAL |
| K070773 | AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR | Oct 11, 2007 | Substantially Equivalent | AXYA MEDICAL, INC. |
| K071704 | SLEEVE AND BUTTON SOFT TISSUE DEVICES | Sep 17, 2007 | Substantially Equivalent | BIOMET SPORTS MEDICINE, INC. |
| K070780 | CONMED LINVATEC XO BUTTON | Aug 21, 2007 | Substantially Equivalent | CONMED LINVATEC |
| K071586 | BIORAPTOR 2.3 PK SUTURE ANCHOR | Aug 17, 2007 | Substantially Equivalent | SMITH & NEPHEW INC., ENDOSCOPY DIVISION |
| K071520 | RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X | Aug 10, 2007 | Substantially Equivalent | CORE ESSENCE ORTHOPAEDICS, LLC |
| K071374 | OPUS TWINLOCK KNOTLESS FIXATION DEVICE | Aug 02, 2007 | Substantially Equivalent | ARTHROCARE CORP. |
| K070882 | STRYKER PEEK TWINLOOP TAC | Jul 20, 2007 | Substantially Equivalent | Stryker Endoscopy |
| K071569 | ALLTHREAD PEEK ANCHOR WITH TANTALUM MARKER | Jul 02, 2007 | Substantially Equivalent | BIOMET, INC. |
| K070908 | SMITH & NEPHEW KINSA RC SUTURE ANCHOR | May 16, 2007 | Substantially Equivalent | SMITH & NEPHEW INC., ENDOSCOPY DIVISION |
| K070758 | STRYKER PEEK ZIP SUTURE ANCHOR | May 16, 2007 | Substantially Equivalent | Stryker Endoscopy |
| K070227 | OPUS MAGNUM PI KNOTLESS FIXATION DEVICE | Apr 16, 2007 | Substantially Equivalent | ARTHROCARE CORP. |
| K070167 | ENDOBUTTON DIRECT | Apr 12, 2007 | Substantially Equivalent | SMITH & NEPHEW INC., ENDOSCOPY DIVISION |
| K062739 | CINCH BONE ANCHOR SYSTEM | Feb 13, 2007 | Substantially Equivalent | SAPPHIRE MEDICAL, INC |
| K063577 | FEMORAL INTRAFIX SCREW AND SHEATH | Jan 25, 2007 | Substantially Equivalent | JOHNSON & JOHNSON COMPANY |
| K063499 | MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM | Dec 19, 2006 | Substantially Equivalent | SCANDIUS BIOMEDICAL, INC. |
| K061294 | KFX KNOTLESS FIXATION SYSTEM | Jul 19, 2006 | Substantially Equivalent | KFX MEDICAL |
| K061349 | OPUS LABRALOCK P KNOTLESS FIXATION DEVICE | Jul 14, 2006 | Substantially Equivalent | ARTHROCARE CORP. |
| K061154 | KINSA SUTURE ANCHOR | Jun 08, 2006 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K053461 | EZLOC FEMORAL FIXATION DEVICE | Feb 03, 2006 | Substantially Equivalent | ARTHROTEK, INC. |
| K052810 | SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM | Dec 20, 2005 | Substantially Equivalent | SCANDIUS BIOMEDICAL, INC. |
| K052572 | ANSPACH KNOTLESS ANCHOR | Dec 05, 2005 | Substantially Equivalent | THE ANSPACH EFFORT, INC. |
| K052491 | AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR | Oct 07, 2005 | Substantially Equivalent | AXYA MEDICAL, INC. |
| K051069 | NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER | Jun 29, 2005 | Substantially Equivalent | ARTHROTEK, INC. |
| K050227 | THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER | Mar 02, 2005 | Substantially Equivalent | LINVATEC CORP. |
| K042914 | OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE | Nov 12, 2004 | Substantially Equivalent | OPUS MEDICAL, INC. |
| K042460 | TI - SCREW ANCHOR SP | Oct 29, 2004 | Substantially Equivalent | ARTHROTEK, INC. |
| K041713 | SUPER REVO HERCULINE SUTURE ANCHOR | Jul 22, 2004 | Substantially Equivalent | LINVATEC CORP. |
| K041440 | OPUS MAGNUM ANCHOR WITH INSERTER | Jun 25, 2004 | Substantially Equivalent | OPUS MEDICAL, INC. |
| K041310 | STRYKER WEDGE SUTURE ANCHOR SYSTEM | Jun 14, 2004 | Substantially Equivalent | Stryker Endoscopy |
| K041261 | FEMORAL HOOK | Jun 07, 2004 | Substantially Equivalent | ARTHROTEK, INC. |
| K033838 | TITANIUM TOGGLE BUTTON(S) | Feb 13, 2004 | Substantially Equivalent | BIOMET MANUFACTURING, INC. |
| K023963 | ADHOC CLAW | May 05, 2003 | Substantially Equivalent | FUTURE MEDICAL SYSTEMS, INC. |
| K022853 | ENDOTACK | Nov 25, 2002 | Substantially Equivalent | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K022827 | ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR | Nov 22, 2002 | Substantially Equivalent | LINVATEC CORP. |
| K022207 | AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM | Oct 04, 2002 | Substantially Equivalent | AXYA MEDICAL, INC. |
| K020172 | OPUS MAGNUM ANCHOR & INSTRUMENT SET | Jul 22, 2002 | Substantially Equivalent | OPUS MEDICAL, INC. |
| K013553 | PRE-LOADED ULTRAFIX RC | Dec 19, 2001 | Substantially Equivalent | LINVATEC CORP. |
| K013334 | ENDOFLIP | Dec 13, 2001 | Substantially Equivalent | ARTHOCARE CORPORATION |
| K013557 | LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW | Nov 16, 2001 | Substantially Equivalent | WALTER LORENZ SURGICAL, INC. |
| K012503 | METAL SCREW ANCHOR | Oct 22, 2001 | Substantially Equivalent | BIOMET MANUFACTURING, INC. |
| K011912 | MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000 | Aug 31, 2001 | Substantially Equivalent | AXYA MEDICAL, INC. |
| K011007 | TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55 | Jun 12, 2001 | Substantially Equivalent | ARTHREX, INC. |
| K011390 | BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM | Jun 06, 2001 | Substantially Equivalent | DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
| K010457 | ARTHREX TWISTLOC SUTURE ANCHOR, MODEL AR-1924 | May 14, 2001 | Substantially Equivalent | ARTHREX, INC. |
| K002829 | DJ ORTHOPEDICS FEMORAL ANCHOR | Mar 26, 2001 | Substantially Equivalent | DJ ORTHOPEDICS, LLC |
| K003971 | AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR | Mar 21, 2001 | Substantially Equivalent | AXYA MEDICAL, INC. |
| K003960 | DJ ORTHOPEDICS TIBIAL ANCHOR | Mar 21, 2001 | Substantially Equivalent | DJ ORTHOPEDICS, LLC |
| K003648 | FREEDLAND TENSION SYSTEM | Feb 23, 2001 | Substantially Equivalent | ETZEM TECHNOLOGIES, INC. |
| K010121 | STERILE BUTTON PLATE | Feb 09, 2001 | Substantially Equivalent | SYNTHES (USA) |
| K002600 | LITWIN CRUICATE ANCHOR | Nov 15, 2000 | Substantially Equivalent | INSTRUMENT MAKAR, INC. |
| K994364 | SYNTHES BUTTON PLATE | Mar 15, 2000 | Substantially Equivalent | SYNTHES (USA) |
| K000279 | STAPLETAC2 BONE ANCHOR SYSTEM | Mar 01, 2000 | Substantially Equivalent | AMERICAN MEDICAL SYSTEMS, INC. |
| K993657 | ACUMED SUTURE ANCHOR | Jan 13, 2000 | Substantially Equivalent | ACUMED, INC. |
| K993261 | TALON ANCHOR SNAP-PAK | Dec 02, 1999 | Substantially Equivalent | MITEK PRODUCTS |
| K992458 | RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454 | Oct 14, 1999 | Substantially Equivalent | INNOVASIVE DEVICES, INC. |
| K992377 | RC TACK | Oct 08, 1999 | Substantially Equivalent | INNOVASIVE DEVICES, INC. |
| K990295 | BONE ANCHOR SYSTEM III (BAS III) | Mar 05, 1999 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K990156 | MULTITAK SS BUTTONS | Mar 05, 1999 | Substantially Equivalent | BONUTTI RESEARCH |
| K990160 | MICROTAC-BONE ANCHOR SYSTEM | Feb 16, 1999 | Substantially Equivalent | INFLUENCE, INC. |
| K990095 | STRAIGHT-IN-ORTHOPEDIC BONE SCREW FIXATION SYSTEM | Feb 01, 1999 | Substantially Equivalent | INFLUENCE, INC. |
| K982751 | IMPLEX SCREW AND WASHER SYSTEM | Feb 01, 1999 | Substantially Equivalent | IMPLEX CORP. |
| K983560 | INNOVASIVE DEVICES INTRATUNNEL TIBIAL FIXATION FASTENER | Jan 28, 1999 | Substantially Equivalent | INNOVASIVE DEVICES, INC. |
| K984200 | STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE | Jan 21, 1999 | Substantially Equivalent | R. THOMAS GROTZ, M.D., INC. |
| K983557 | STRYKER WEDGE SUTURE ANCHOR | Dec 18, 1998 | Substantially Equivalent | Stryker Endoscopy |
| K983169 | POLYMER THREADED ANCHOR | Dec 16, 1998 | Substantially Equivalent | ORTHOPAEDIC BIOSYSTEMS, LTD. |
| K983818 | MITEK FASTIN RC ANCHOR | Nov 23, 1998 | Substantially Equivalent | MITEK PRODUCTS |
| K983056 | INNOVASIVE TIBIAL FASTENER | Oct 13, 1998 | Substantially Equivalent | INNOVASIVE DEVICES, INC. |
| K982571 | KSEA FLIPPTACK | Sep 22, 1998 | Substantially Equivalent | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K982169 | SHERLOCK THREADED SUTURE ANCHOR (TIN COATED) | Sep 14, 1998 | Substantially Equivalent | DOCTOR'S RESEARCH GROUP, INC. |
| K982155 | SHORT STRAIGHT-IN BONE SCREW FIXATION SYSTEM | Aug 31, 1998 | Substantially Equivalent | INFLUENCE, INC. |
| K974847 | 5.0MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22255, 3.5MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22235 | Aug 06, 1998 | Substantially Equivalent | ARTHREX, INC. |
| K981692 | MENISCAL REPAIR DEVICE | Jul 27, 1998 | Substantially Equivalent | LINVATEC CORP. |
| K981967 | WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCRE | Jul 17, 1998 | Substantially Equivalent | ARTHROTEK/BIOMET, INC. |
| K981764 | LM ANCHOR | Jul 13, 1998 | Substantially Equivalent | LI MEDICAL TECHNOLOGIES, INC. |
| K981755 | LM ANCHOR | Jul 13, 1998 | Substantially Equivalent | LI MEDICAL TECHNOLOGIES, INC. |
| K981688 | ANSPACH SUTURE ANCHOR | Jul 13, 1998 | Substantially Equivalent | THE ANSPACH EFFORT, INC. |
| K981193 | INNOVASIVE 3.5MM METAL ROC XS SUTURE BONE FASTENER | Jun 16, 1998 | Substantially Equivalent | INNOVASIVE DEVICES, INC. |
| K980595 | DEPUY ORTHOTECH CATERA SUTURE ANCHOR | May 11, 1998 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K980491 | INNOVASIVE LINX TIBIAL LIGAMENT FASTENER | Apr 29, 1998 | Substantially Equivalent | INNOVASIVE DEVICES, INC. |
| K980334 | INNOVASIVE 10MM LINX HT LIGAMENT FASTENER | Apr 27, 1998 | Substantially Equivalent | INNOVASIVE DEVICES, INC. |
| K973874 | ACL CLIP-IN PLATE | Apr 24, 1998 | Substantially Equivalent | INNOVASIVE DEVICES, INC. |
| K973775 | HARPOON SUTURE ANCHORS | Apr 16, 1998 | Substantially Equivalent | BIOMET, INC. |
| K980103 | ACUMED SUTURE ANCHOR | Mar 16, 1998 | Substantially Equivalent | ACUMED, INC. |
| K974049 | INNOVASIVE LINX BT 10MM LIGAMENT FASTENER | Feb 18, 1998 | Substantially Equivalent | INNOVASIVE DEVICES, INC. |
| K974345 | MITEK KNOTLESS ANCHOR | Feb 13, 1998 | Substantially Equivalent | MITEK PRODUCTS |
| K972326 | PEBA ANCHOR/SUTURE COMBINATION | Feb 06, 1998 | Substantially Equivalent | ORTHOPAEDIC BIOSYSTEMS, LTD. |
| K974136 | CRANIOFACIAL ANCHORS | Jan 30, 1998 | Substantially Equivalent | BIOMET, INC. |
| K970119 | MITEK ABSORBABLE POLYDIOXANONE (PDS) H FIX | Jan 30, 1998 | Substantially Equivalent | MITEK PRODUCTS |
| K973323 | ACL CLIP-IN | Dec 01, 1997 | Substantially Equivalent | INNOVASIVE DEVICES, INC. |
| K973009 | MITEK NON ABSORBABLE POLYPROPYLENE H FIX | Nov 10, 1997 | Substantially Equivalent | MITEK PRODUCTS |
| K963502 | CSCO FOREHEAD FIXATION SYSTEM | Oct 28, 1997 | Substantially Equivalent | HOWMEDICA CORP. |
| K973015 | MULTITAK SS SUTURE SYSTEM | Oct 09, 1997 | Substantially Equivalent | BONUTTI RESEARCH |
| K972622 | STRAIGHT-IN BONE SCREW FIXATION SYSTEM | Oct 09, 1997 | Substantially Equivalent | INFLUENCE, INC. |
| K972438 | INNOVASIVE 2.3MM ROC XS SUTURE BONE FASTENER | Sep 26, 1997 | Substantially Equivalent | INNOVASIVE DEVICES, INC. |
| K972356 | INNOVASIVE 2.3MM ROC EZ SUTURE BONE FASTENER | Aug 26, 1997 | Substantially Equivalent | INNOVASIVE DEVICES, INC. |
| K971922 | INNOVASIVE 2.8MM AND 3.5MM ROC EZ SUTURE BONE FASTENER | Aug 07, 1997 | Substantially Equivalent | INNOVASIVE DEVICES, INC. |
| K971802 | VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION | Jul 30, 1997 | Substantially Equivalent | LOUISVILLE LABORATORIES, INC. |
| K971791 | VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION | Jul 30, 1997 | Substantially Equivalent | LOUISVILLE LABORATORIES, INC. |
| K971723 | FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM) | Jul 30, 1997 | Substantially Equivalent | ARTHREX, INC. |
| K971332 | AMS MAINSTAY UROLOGIC BONE ANCHOR | Jul 09, 1997 | Substantially Equivalent | AMERICAN MEDICAL SYSTEMS, INC. |
| K971282 | ANCHORLOK AND ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM | Jun 27, 1997 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K971144 | MULTITAK SS SUTURE SYSTEM | Jun 25, 1997 | Substantially Equivalent | BONUTTI RESEARCH |
| K971139 | BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT | Jun 25, 1997 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K963932 | PRELOADED SOFT TISSUE ANCHOR | Jun 20, 1997 | Substantially Equivalent | LINVATEC CORP. |
| K970423 | INNOVASIVE ROCLET BONE TUNNEL AUGMENTATION DEVICE | Apr 30, 1997 | Substantially Equivalent | INNOVASIVE DEVICES, INC. |
| K970292 | IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW | Apr 23, 1997 | Substantially Equivalent | INFLUENCE, INC. |
| K970316 | INNOVASIVE 8MM LIGAMENT FASTENER | Apr 16, 1997 | Substantially Equivalent | INNOVASIVE DEVICES, INC. |
| K970089 | INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTURE BONE FASTENER | Mar 25, 1997 | Substantially Equivalent | INNOVASIVE DEVICES, INC. |
| K964945 | INNOVASIVE DEVICES ROTATOR CUFF FASTNER | Feb 24, 1997 | Substantially Equivalent | INNOVASIVE DEVICES, INC. |
| K965111 | STABILIZER SOFT TISSUE ANCHOR MODEL NUMBER TA1005, TA1008, ANCHOR INSERTER/SUTURE ORGANIZER MODEL NUMBERS AI1005, AI1008 | Feb 18, 1997 | Substantially Equivalent | R. THOMAS GROTZ, M.D., INC. |
| K965069 | ANSPACH SUTURE ANCHOR | Feb 12, 1997 | Substantially Equivalent | THE ANSPACH EFFORT, INC. |
| K964927 | STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZER, 8MM MODEL AI1008, STABILIZER DRILL, 8 | Feb 07, 1997 | Substantially Equivalent | R. THOMAS GROTZ, M.D., INC. |
| K964786 | ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM | Feb 06, 1997 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K964532 | MULTITAK SS SUTURE SYSTEM | Feb 03, 1997 | Substantially Equivalent | BONUTTI RESEARCH |
| K964324 | MULTITAK SS SUTURE SYSTEM | Jan 10, 1997 | Substantially Equivalent | BONUTTI RESEARCH |
| K963686 | ANSPACH SUTURE ANCHOR (MODIFIED) | Nov 25, 1996 | Substantially Equivalent | THE ANSPACH EFFORT, INC. |
| K963288 | LM BONE ANCHOR | Nov 13, 1996 | Substantially Equivalent | LI MEDICAL TECHNOLOGIES, INC. |
| K963812 | LM BONE ANCHOR (ORTHOPEDICS) | Nov 12, 1996 | Substantially Equivalent | LI MEDICAL TECHNOLOGIES, INC. |
| K962511 | MITEK MICRO ANCHOR | Nov 06, 1996 | Substantially Equivalent | MITEK PRODUCTS |
| K963402 | INNOVASIVE 2.8MM ROC SUTURE BONE FASTENER AND 3.5MM ROC SUTURE BONE FASTENER | Nov 04, 1996 | Substantially Equivalent | INNOVASIVE DEVICES, INC. |
| K961094 | MITEK THREADED ANCHOR (MODIFICATION) | Oct 03, 1996 | Substantially Equivalent | MITEK PRODUCTS |
| K963217 | ANCHORLOK II SOFT TISSUE ANCHOR SYSTEM | Oct 02, 1996 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K963200 | QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM | Oct 02, 1996 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K962397 | STATAK SOFT TISSUE ATTACHMENT DEVICE | Aug 27, 1996 | Substantially Equivalent | ZIMMER, INC. |
| K962194 | MLI SOFT TISSUE SCREW & WASHER SYSTEM | Jul 30, 1996 | Substantially Equivalent | MEDICINE LODGE, INC. |
| K960825 | LM ANCHOR OR OTHER PROPRIETARY NAME | Apr 30, 1996 | Substantially Equivalent | LI MEDICAL TECHNOLOGIES, INC. |
| K954683 | QUESTLOCK ACL FIXATOR | Apr 23, 1996 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K960516 | FASTAK SUTURE ANCHOR | Apr 18, 1996 | Substantially Equivalent for Some Indications | ARTHREX, INC. |
| K960439 | LM BONE ANCHOR | Apr 18, 1996 | Substantially Equivalent | LI MEDICAL TECHNOLOGIES, INC. |
| K960448 | LM ANCHOR | Apr 17, 1996 | Substantially Equivalent | LI MEDICAL TECHNOLOGIES, INC. |
| K934183 | BONUTTI ANCHOR | Apr 03, 1996 | Substantially Equivalent for Some Indications | APOGEE MEDICAL PRODUCTS, INC. |
| K954338 | INNOVASIVE 1.9MM ROC SUTURE BONE FASTENER | Mar 21, 1996 | Substantially Equivalent for Some Indications | INNOVASIVE DEVICES, INC. |
| K953954 | PRELOADED SOFT TISSUE ANCHOR | Feb 20, 1996 | Substantially Equivalent for Some Indications | LINVATEC CORP. |
| K953560 | MITEK THREADED ANCHOR (FASTIN) | Jan 31, 1996 | Substantially Equivalent for Some Indications | MITEK SURGICAL PRODUCTS, INC. |
| K953877 | MITEK GII ANCHOR | Dec 29, 1995 | Substantially Equivalent | MITEK SURGICAL PRODUCTS, INC. |
| K952237 | INNOVASICE 2.8MM & 3.5MM ROC SUTURE BONE FASTENER | Dec 08, 1995 | Substantially Equivalent for Some Indications | INNOVASIVE DEVICES, INC. |
| K951451 | PEBA ANCHOR (MULTIPLE SIZES) | Oct 31, 1995 | Substantially Equivalent for Some Indications | ORTHOPAEDIC BIOSYSTEMS, LTD. |
| K953702 | WASHER | Oct 25, 1995 | Substantially Equivalent | LINVATEC CORP. |
| K953264 | QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM | Oct 20, 1995 | Substantially Equivalent for Some Indications | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K934327 | ARTHREX SUTURE ANCHOR SCREW SYSTEM | Sep 15, 1995 | Substantially Equivalent | ARTHREX, INC. |
| K951565 | INNOVASIVE DEVICES ROTATOR CUFF FASTENER | Sep 08, 1995 | Substantially Equivalent | INNOVASIVE DEVICES, INC. |
| K953459 | ACUFEX TAG ANCHOR | Aug 23, 1995 | Substantially Equivalent | ACUFEX MICROSURGICAL, INC. |
| K944831 | INNOVASIVE 1.9MM, 2.8MM, 3.5MM, 4.5MM ROC SUTURE BONE FASTENER | Feb 01, 1995 | Substantially Equivalent for Some Indications | INNOVASIVE DEVICES, INC. |
FEI Numbers
This FDA classification entry is associated with 263 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 263 registration numbers. Click on an entry to view related FDA registrations.