Panels › Orthopedic › Product code JDR · Class 2
Staple, Fixation, Bone
Regulation 888.3030
2510(k)s in 12 months (233 all time)
2recalls in 12 months (37 all time)
35recalls that name a 510(k)
Top companies in JDR
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 1, 2017 | K163440 | Stealth Staple System First Ray, LLC | JDR |
| Feb 1, 2017 | K161587 | Memodyn Staple Austin & Associates, Inc./Telos Medical Equipment | JDR |
| Oct 24, 2016 | K161426 | NeoSpan Compression Staple Impant w/instruments In2bones USA, LLC | JDR |
| Jul 26, 2016 | K160813 | EasyStep Stryker GmbH | JDR |
| Apr 8, 2016 | K153622 | First Ray Internal Bone Staple System First Ray, LLC | JDR |
| Mar 21, 2016 | K153770 | OS2(R)-VP Varisation Staple In2bones Sas, FR | JDR |
| Feb 18, 2016 | K153395 | OS2-C Compression Staple In2bones Sas, FR | JDR |
| Jan 28, 2016 | K153129 | dynaMX Tabbed Staple Mx Orthopedics, Corp. | JDR |
| Dec 28, 2015 | K151762 | PediatrOS RigidTack/FlexTack Merete Medical GmbH, DE | JDR |
| Oct 2, 2015 | K151615 | TiTHON Staple with OsseoTi Technology Biomet Manufacturing Corp | JDR |
| Sep 4, 2015 | K151160 | Arcus Staple System Nextremity Solutions, Inc. | JDR |
| Jun 17, 2015 | K143622 | dynaMX Compression Staple Mx Orthopedics, Corp. | JDR |
| May 11, 2015 | K150125 | Elite Nitinol Fixation System Biomedical Enterprises, Inc. | JDR |
| Feb 26, 2015 | K143323 | OS2-V Varisation Staple In2bones Sas, FR | JDR |
| Jan 20, 2015 | K143037 | SnapShot Fixation System Biomet Manufacturing Corp | JDR |
| Dec 19, 2014 | K142111 | ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS STAPLE Novatsep, FR | JDR |
| Nov 19, 2014 | K141263 | TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS Biomet Manufacturing Corp | JDR |
| Nov 17, 2014 | K142292 | Speed, Speed Shift, Speed Titan, Speed Arc Biomedical Enterprises, Inc. | JDR |
| Oct 24, 2014 | K142727 | CrossCLIP Implant System Orthodiscovery Group, LLC(D.B.A. Crossroads Extremity Systems | JDR |
| Aug 21, 2014 | K142148 | ORTHOHELIX STAPLE SYSTEM Orthohelix Surgical Designs, Inc. | JDR |
| Jul 11, 2014 | K141550 | INSTAFIX SHAPE MEMORY FIXATION SYSTEM Ot Medical | JDR |
| Jun 2, 2014 | K140358 | COMPRESSYN STAPLE Dallen Medical, Inc. | JDR |
| Apr 17, 2014 | K133270 | SPEED ARC Biomedical Enterprises, Inc. | JDR |
| Apr 7, 2014 | K133844 | SPEED TRIAD Biomedical Ent., Inc. | JDR |
| Mar 19, 2014 | K133780 | SPEED XL Biomedical Ent., Inc. | JDR |
| Feb 6, 2014 | K133523 | STAPIX SUPERELASTIC IMPLANT BONE STAPLES Instratek, Inc. | JDR |
| Dec 30, 2013 | K132875 | COMPRESSYN STAPLE Dallen Medical, Inc. | JDR |
| Aug 28, 2013 | K131061 | RESTORE BUNION CORRECTION SYSTEM Nextremity Solutions | JDR |
| Aug 15, 2013 | K130832 | ORTHOHELIX STAPLE SYSTEM Orthohelix Surgical Designs, Inc. | JDR |
| Jul 10, 2013 | K124045 | FUSEFORCE IMPLANT SYSTEM Solana Surgical, LLC | JDR |
| May 14, 2013 | K124022 | SPEED SHIFT Biomedical Enterprises, Inc. | JDR |
| May 3, 2013 | K123926 | METASURG NITINOL STAPLE IMPLANT Metasurg | JDR |
| Mar 12, 2013 | K122113 | MEMORY METAL STAPLES, EASYCLIP Stryker Corp. | JDR |
| Feb 7, 2013 | K122871 | COMPRESSYN STAPLE Dallen Medical, Inc. | JDR |
| Jan 3, 2013 | K123363 | SUPER STAPLE(TM) CLASSIC Metric Medical Devices, Inc. | JDR |
| Oct 9, 2012 | K112837 | VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE) Vilex, Inc. | JDR |
| Oct 24, 2011 | K102387 | MEDISCOPE COMPRESSIOPN STAPLE AND ACCESSORIES Mediscope Manufacturing, Inc. | JDR |
| Dec 8, 2010 | K102143 | SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM Suspension Orthopaedic Solutions, LLC | JDR |
| Sep 3, 2010 | K102107 | OSSTAPLE CHILL Biomedical Ent., Inc. | JDR |
| Nov 3, 2008 | K082215 | OSTEORAPTOR SUTURE ANCHOR Smith & Nephew Inc., Endoscopy Division | JDR |
| Jul 17, 2008 | K081172 | COMPOSITE HITCH SUTURE ANCHOR Biomet Manufacturing Corp | JDR |
| Jul 16, 2008 | K081098 | ENDOBUTTON CONTINUOUS LOOP (CL) Smith & Nephew Inc., Endoscopy Division | JDR |
| May 2, 2008 | K073281 | CAIS STAPLE Depuy Mitek, A Johnson & Johnson Company | JDR |
| Feb 13, 2008 | K080111 | ARTHREX COMPRESSION STAPLE Arthrex, Inc. | JDR |
| Oct 29, 2007 | K072298 | BIOPRO MEMORY STAPLE, MODELS 18062-18073 Biopro, Inc. | JDR |
| Aug 15, 2007 | K071477 | REVERTO 55 AND 37 SHAPE MEMORY STAPLES Core Essence Orthopaedics, LLC | JDR |
| Aug 3, 2007 | K071637 | INTRINSIC THERAPEUTICS FIXATION STAPLE Intrinsic Therapeutics Incorporated | JDR |
| Aug 2, 2007 | K071479 | SBI STAFIX Small Bone Innovations, Inc. | JDR |
| Jun 29, 2007 | K071257 | MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD Depuy Mitek, A Johnson & Johnson Company | JDR |
| May 18, 2007 | K070688 | NEXFIX COMPRESSION STAPLE Nexa Orthopedics, Inc. | JDR |
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