Panels › Orthopedic › Product code HRS · Class 2
Plate, Fixation, Bone
Regulation 888.3030
62510(k)s in 12 months (1,332 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 |
| Wright Medical Technology Inc | 0 | 43 |
| Arthrex, Inc. | 39 | 3 |
| DePuy Orthopaedics, Inc. | 18 | 14 |
| Medartis AG | 32 | 0 |
| TriMed, Inc. | 25 | 6 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 3, 2019 | K191344 | Arthrex Mini Comprehensive Fixation System 2.0mm & 2.4mm Module Arthrex, Inc. | HRS |
| Sep 30, 2019 | K191848 | APTUS Wrist Spanning Plates 2.5 Medartis AG, CH | HRS |
| Sep 16, 2019 | K191641 | AFFINITY Variable Angle Distal Radius System, AFFINITY Variable Angle Distal Radius Plates, AFFINITY Variable Angl Industrias Medicas Sampedro S.A.S, CO | HRS |
| Sep 13, 2019 | K192217 | NCB Plating System Distal Femur and Proximal Tibia Zimmer GmbH, CH | HRS |
| Aug 23, 2019 | K191412 | VariAx 2 System, VariAx 2 Mini Fragment System Stryker GmbH | HRS |
| Aug 22, 2019 | K192021 | NCB Polyaxial Locking Plate System Zimmer GmbH, CH | HRS |
| Aug 12, 2019 | K191009 | Arsenal Plating System Trilliant Surgical | HRS |
| Aug 8, 2019 | K190385 | CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System In2bones USA, LLC | HRS |
| Aug 6, 2019 | K190992 | OrthoPediatrics PediFoot Deformity Corrections System OrthoPediatrics Corp. | HRS |
| Aug 1, 2019 | K182818 | LOQTEQ VA Calcaneus Plate 3.5 Aap Implantate AG, DE | HRS |
| Jul 29, 2019 | K191535 | CoLink® Mini Plating System In2bones USA, LLC | HRS |
| Jul 23, 2019 | K190963 | DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional Synthes (USA) Products, LLC | HRS |
| Jul 17, 2019 | K191711 | ORTHOLOC SPS Shoulder Plating System Tornier, Inc. | HRS |
| Jun 21, 2019 | K190750 | DePuy Synthes Plates and Screws Portfolio DePuy Synthes | HRS |
| Jun 19, 2019 | K182785 | LOQTEQ VA Foot Plates 2.5 Aap Implantate AG, DE | HRS |
| Jun 10, 2019 | K182650 | Arzzt Distal Radius and Ulna System Truemed Group, LLC | HRS |
| Jun 7, 2019 | K190388 | RIVAL View Plating Systems and Reduce Fracture Plating Systems Orthofix Srl, IT | HRS |
| Jun 6, 2019 | K183620 | PROSTEP TBC Implant System Wrightmedicaltechnologyinc | HRS |
| May 14, 2019 | K190670 | ORTHOLOC 2 Lapidus with Rotation System Wrightmedicaltechnologyinc | HRS |
| May 3, 2019 | K190409 | MatrixRIB Fixation System DePuy Synthes | HRS |
| Apr 19, 2019 | K190415 | ATLAS Plating System MiRus, LLC | HRS |
| Apr 12, 2019 | K190658 | MIS Bunion Plating System Crossroads Extremity Systems, LLC | HRS |
| Apr 12, 2019 | K190365 | Baby Gorilla/Gorilla Plating System Paragon 28, Inc. | HRS |
| Mar 11, 2019 | K190253 | EVOS Small Fragment Upper Extremity Plates Line Additions Smith & Nephew, Inc. | HRS |
| Mar 5, 2019 | K183172 | Stryker SternalPlate System Stryker | HRS |
| Mar 4, 2019 | K181843 | MLP Special Locking Bone Plate System Maxxion Medical, LLC / Baumer SA | HRS |
| Feb 19, 2019 | K181872 | MIS Bunion System Crossroads Extremity Systems, LLC | HRS |
| Feb 14, 2019 | K183317 | AdvantageRib System Sig Medical Corporation | HRS |
| Feb 13, 2019 | K182991 | EPIC Extremity Fusion Plate System Epic Extremity, LLC | HRS |
| Jan 25, 2019 | K183321 | Treace Medical Concepts (TMC) Plating System Treace Medical Concepts, Inc. | HRS |
| Jan 10, 2019 | K183011 | Additive Orthopaedics Patient Specific 3D Locking Lattice Plates Additive Orthopaedics | HRS |
| Dec 26, 2018 | K182783 | DePuy Synthes Trauma Orthopedic Nail Implants DePuy Synthes | HRS |
| Dec 21, 2018 | K180821 | TruMatch Graft Cage - Long Bone Synthes (Usa), LLC | HRS |
| Dec 10, 2018 | K182810 | Distal Radius Plating System Miami Device Solutions, LLC | HRS |
| Nov 20, 2018 | K181806 | ARIX Sternal System Jeil Medical Corporation, KR | HRS |
| Nov 16, 2018 | K182201 | Stratum Foot Plating System Nextremity Solutions, Inc. | HRS |
| Nov 16, 2018 | K182179 | AdvantageRib Anterior System Sig Medical Corp. | HRS |
| Nov 1, 2018 | K181820 | Medline Unite Mini Plates and Screws Medline Industries, Inc. | HRS |
| Nov 1, 2018 | K180310 | DePuy Synthes Trauma Orthopedic Plates and Screws Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | HRS |
| Oct 30, 2018 | K182466 | AOS Calcaneal Plating System Advanced Orthopaedic Solutions | HRS |
| Oct 22, 2018 | K180554 | ANTHEM Fracture System Globus Medical, Inc. | HRS |
| Oct 19, 2018 | K180213 | Titanium TomoFix Medial High Tibia Plate Anatomical Synthes (USA) Products, LLC | HRS |
| Oct 11, 2018 | K182015 | Piccolo Composite® Plate System CarboFix Orthopedics , Ltd., IL | HRS |
| Oct 11, 2018 | K181091 | AxSOS 3 Ti Stryker GmbH, CH | HRS |
| Oct 10, 2018 | K182492 | Geminus Volar Distal Radius Plate System Skeletal Dynamics, LLC | HRS |
| Oct 5, 2018 | K181587 | ORTHOLOC SPS Shoulder Plating System Tornier, Inc. | HRS |
| Oct 4, 2018 | K180736 | WishBone Medical Plate and Screw System Wishbone Medical, Inc. | HRS |
| Oct 3, 2018 | K180972 | ARIX Clavicle System Jeil Medical Corporation, KR | HRS |
| Sep 27, 2018 | K182402 | CoLink View Plating System In2bones USA, LLC | HRS |
| Sep 18, 2018 | K171904 | Tandry Locking Plate System Microware Precision Co., Ltd., TW | HRS |
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