Panels › Orthopedic › Product code HRS · Class 2
Plate, Fixation, Bone
Regulation 888.3030
64510(k)s in 12 months (1,334 all time)
20recalls in 12 months (288 all time)
277recalls that name a 510(k)
Top companies in HRS
| Company | 510(k)s | Recalls |
|---|---|---|
| Synthes | 104 | 8 |
| Smith & Nephew | 37 | 16 |
| Biomet | 21 | 28 |
| Wrightmedicaltechnologyinc | 45 | 0 |
| Zimmer GmbH | 32 | 12 |
| Arthrex, Inc. | 40 | 3 |
| Wright Medical Technology Inc | 0 | 43 |
| DePuy Orthopaedics, Inc. | 18 | 14 |
| Medartis AG | 32 | 0 |
| TriMed, Inc. | 25 | 6 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 11, 2016 | K153573 | Converge Biomedical Enterprises, Inc. | HRS |
| Aug 2, 2016 | K161896 | Biomet Microfixation Sternal Closure System Biomet Microfixation | HRS |
| Aug 2, 2016 | K161864 | ARIX Foot System Jeil Medical Corporation, KR | HRS |
| Jul 26, 2016 | K161048 | Conventus Orthopaedics Ulna Fixation System Conventus Orthopaedics, Inc. | HRS |
| Jun 17, 2016 | K153374 | CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System Orthocare, IN | HRS |
| Jun 10, 2016 | K160995 | NEOVIEW Plating System In2bones Sas, FR | HRS |
| May 26, 2016 | K153379 | AxSOS 3Ti Stryker GmbH, CH | HRS |
| May 19, 2016 | K161041 | OsteoMed ExtremiLOCK Wrist Plating System Osteomed | HRS |
| May 17, 2016 | K153716 | GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. Gpc Medical, Ltd., IN | HRS |
| May 17, 2016 | K152062 | BIOFOAM Bone Wedge Wrightmedicaltechnologyinc | HRS |
| Apr 22, 2016 | K160633 | G3(TM) Active Plate(R) Small Fragment System Genesis Fracture Care, Inc. | HRS |
| Apr 22, 2016 | K160300 | MotoBand(TM) CP Implant System Crossroads Extremity Systems, LLC | HRS |
| Apr 22, 2016 | K160177 | Gridlock Ankle Plating System Trilliant Surgical, Ltd. | HRS |
| Apr 6, 2016 | K153482 | KLS Martin Thoracic Plating System KLS-Martin L.P. | HRS |
| Mar 25, 2016 | K160191 | Align Anterior Ankle Fusion Plate Extremity Medical, LLC | HRS |
| Mar 24, 2016 | K152253 | Biomet Microfixation RibFix Blu Thoracic Fixation System Biomet Microfixation | HRS |
| Mar 9, 2016 | K160002 | Piccolo Composite(R) Distal Volar Radius Plate System CarboFix Orthopedics , Ltd., IL | HRS |
| Feb 25, 2016 | K151508 | IRENE Locking Compression Plate System Tianjin Zhengtian Medical Instrument Co., Ltd., CN | HRS |
| Feb 9, 2016 | K153340 | Epic Extremity Plate System Epic Extremity, LLC | HRS |
| Jan 29, 2016 | K151735 | TriMed Humeral Supracondylar Fixation System TriMed, Inc. | HRS |
| Jan 28, 2016 | K151716 | Cable-Ready Cable Grip System: Cable-Ready Bone Plate System Zimmer, Inc. | HRS |
| Jan 21, 2016 | K153034 | aap LOQTEQ VA Radius Set 2.5 Aap Implantate AG, DE | HRS |
| Jan 14, 2016 | K151468 | ARIX Wrist System Jeil Medical Corporation, KR | HRS |
| Jan 7, 2016 | K153531 | Treace Medical Concepts (TMC) Plating System Treace Medical Concepts, Inc. | HRS |
| Dec 21, 2015 | K152548 | AXI+LINE Proximal Bunion Correction System Nextremity Solutions, Inc. | HRS |
| Dec 21, 2015 | K152145 | OsteoMed ExtremiLOCK Wrist Plating System Osteomed | HRS |
| Dec 11, 2015 | K152974 | ORTHOLOC® 3Di Foot Plating Reconstruction System Wrightmedicaltechnologyinc | HRS |
| Dec 11, 2015 | K152306 | MotoBand¿ CP Implant System Crossroads Extremity Systems, LLC | HRS |
| Dec 10, 2015 | K152732 | AOS Small Fragment Plating System Avanced Orthopaedic Solutions, Inc. (Aos) | HRS |
| Nov 25, 2015 | K152000 | SMV Scientific Bone Plate and Screw System Smv Scientific | HRS |
| Nov 25, 2015 | K150561 | NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System Narang Medical Limited, IN | HRS |
| Nov 24, 2015 | K152242 | G3¿ Active Plate® Large Fragment System Genesis Fracture Care, Inc. | HRS |
| Nov 12, 2015 | K152976 | VLP Mini-Mod Talus Plates Smith & Nephew, Inc. | HRS |
| Nov 5, 2015 | K152256 | RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and Screws Normed Medizin-Technik GmbH, DE | HRS |
| Nov 3, 2015 | K151019 | SternaLock® 360 Sternal Closure System Biomet Microfixation | HRS |
| Oct 30, 2015 | K152312 | RECON system-V-TEK-IVP Plates and Screws Normed Medizin-Technik GmbH, DE | HRS |
| Oct 30, 2015 | K151886 | Acumed Ankle and Small Fragment Base Set Update Acumed, LLC | HRS |
| Oct 27, 2015 | K151769 | Anchorage 2 CP System Stryker GmbH | HRS |
| Sep 16, 2015 | K152142 | RECON system - MPJ-Plates Normed Medizin-Technik GmbH, DE | HRS |
| Sep 4, 2015 | K151442 | TOTAL COMPRESSION PLATING (TCP) SYSTEM Wrightmedicaltechnologyinc | HRS |
| Aug 28, 2015 | K151732 | Arthrex Fracture Plates Arthrex, Inc. | HRS |
| Aug 27, 2015 | K143721 | PRCT2 Fx Solutions, FR | HRS |
| Aug 13, 2015 | K151379 | Conventus PRS System Conventus Orthopaedics, Inc. | HRS |
| Aug 13, 2015 | K151277 | Airlock® osteosynthesis plate system Novastep, FR | HRS |
| Aug 12, 2015 | K151407 | RECON system Normed Medizin-Technik GmbH, DE | HRS |
| Aug 10, 2015 | K151057 | WASTON Metallic Bone Plate and Screw Systems Changzhou Waston Medical Appliance Co., Ltd., CN | HRS |
| Aug 6, 2015 | K151879 | VariAx 2 One-Third Tubular Plating System Stryker GmbH, DE | HRS |
| Aug 6, 2015 | K151235 | Medline Foot Plates and Screws Medline Industries, Inc. | HRS |
| Aug 3, 2015 | K142943 | Metallic Locking Bone Plate and Screw Canwell Medical Co., Ltd., CN | HRS |
| Jun 30, 2015 | K141680 | AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Lockin Auxein Medical, IN | HRS |
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