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 |
|---|---|---|---|
| Mar 31, 2009 | K090492 | 1.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCREWS DePuy Orthopaedics, Inc. | HRS |
| Mar 20, 2009 | K083843 | LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM DePuy Orthopaedics, Inc. | HRS |
| Mar 6, 2009 | K083694 | SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES Synthes (Usa) | HRS |
| Mar 4, 2009 | K083573 | SYNTHES (USA) 3.5MM LOCKING ATTACHMENT PLATES Synthes (Usa) | HRS |
| Feb 26, 2009 | K083654 | ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM TI-6A1-4V ALLOY, CP GRADE TITANIUM) Zimmer, Inc. | HRS |
| Feb 18, 2009 | K082300 | ANATOMIC LOCKING PLATING SYSTEM DePuy Orthopaedics, Inc. | HRS |
| Feb 6, 2009 | K083447 | MEMOMETAL ANCHORAGE BONE PLATE SYSTEM, MODELS PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50 Memometal Technologies, FR | HRS |
| Jan 30, 2009 | K083286 | ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEM OrthoPediatrics Corp. | HRS |
| Jan 14, 2009 | K083025 | SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR SYSTEM Synthes (Usa) | HRS |
| Jan 7, 2009 | K083032 | PERI-LOC BONE PLATING AND SCREW SYSTEM Smith & Nephew, Inc. | HRS |
| Dec 30, 2008 | K083213 | SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES Synthes (Usa) | HRS |
| Dec 19, 2008 | K081608 | PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS) Toby Orthopaedics, LLC | HRS |
| Dec 18, 2008 | K082527 | ZIMMER UNIVERSAL LOCKING SYSTEM: 3.5 MM LOCKING PLATES AND SCREWS Zimmer, Inc. | HRS |
| Dec 17, 2008 | K082625 | SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES Synthes (Usa) | HRS |
| Dec 11, 2008 | K083364 | 2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424 DePuy Orthopaedics, Inc. | HRS |
| Dec 4, 2008 | K072562 | MICROWARE BONE PLATES AND BONE SCREWS Microware Precision Co., Ltd., TW | HRS |
| Nov 24, 2008 | K082807 | SYNTHES (USA) 3.5 AND 4.5 MM LOCKING COMPRESSION PLATE SYSTEM WITH EXPANDED INDICATIONS Synthes (Usa) | HRS |
| Nov 10, 2008 | K082624 | SYNTHES (USA) 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATES Synthes (Usa) | HRS |
| Nov 7, 2008 | K082072 | SYNTHES (USA) 3.5MM LCP HOOK PLATE Synthes (Usa) | HRS |
| Nov 3, 2008 | K082078 | ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM: DISTAL HUMERAL AND PROXIMAL ULNA PLATES Zimmer, Inc. | HRS |
| Oct 16, 2008 | K081759 | NCB POLYAXIAL LOCKING PLATE SYSTEM, PROXIMAL HUMERAL PLATES, ZIMMER UNIVERSAL LOCKING SYSTEM, 3.5MM TIVANIUM TI-6AL-4V Zimmer GmbH | HRS |
| Sep 9, 2008 | K081374 | CHARLOTTE LISFRANC BONE SCREW, CHARLOTTE LISFRANC PLATE Wrightmedicaltechnologyinc | HRS |
| Sep 8, 2008 | K081623 | SYNTHES RIB FIXATION SYSTEM Synthes (Usa) | HRS |
| Sep 4, 2008 | K080992 | AESCULAP IMPLANT SYSTEMS HIGH TIBIAL OSTEOTOMY PLATING SYSTEM Aesculap Implant Systems, Inc. | HRS |
| Sep 3, 2008 | K081588 | RE-ZORB PLATING SYSTEM Acute Innovations, LLC | HRS |
| Aug 26, 2008 | K081546 | SMALL BONE LOCKING PLATING SYSTEM DePuy Orthopaedics, Inc. | HRS |
| Aug 13, 2008 | K073432 | TRAUSON BONE PLATE Trauson (Jiangsu) Medical Instrument Co., Ltd., CN | HRS |
| Jul 23, 2008 | K081353 | SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEMUR PLATES Synthes (Usa) | HRS |
| Jul 22, 2008 | K081407 | ORTHOPEDIATRICS PEDIPLATES SYSTEM OrthoPediatrics Corp. | HRS |
| Jul 15, 2008 | K073115 | ORTHOMESH Synthes (Usa) | HRS |
| Jul 3, 2008 | K081373 | EVOLVE EPS SYSTEM Wrightmedicaltechnologyinc | HRS |
| Jun 24, 2008 | K073556 | MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS Medxpert GmbH, DE | HRS |
| Jun 18, 2008 | K081106 | PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM VOLAR DISTAL RADIUS LOCKING PLATE FOR THE UPPER EXTREMITY-ASTM F139 Smith & Nephew, Inc. | HRS |
| May 23, 2008 | K080522 | SYNTHES 3.5 MM LCP DISTAL TIBIA T PLATES Synthes (Usa) | HRS |
| Mar 26, 2008 | K080184 | DISTAL HUMERAL PLATES WITH ANGULAR STABILITY I.T.S. Implantat-Technologie-Systeme GmbH | HRS |
| Mar 20, 2008 | K073624 | MODULAR FOOT SYSTEM Orthohelix Surgical Designs, Inc. | HRS |
| Mar 20, 2008 | K072411 | AAP BONE PLATES AND SCREW IMPLANTS Aap Implantate AG, DE | HRS |
| Mar 19, 2008 | K080667 | VARIAX DISTAL RADIUS TORX SCREWS Howmedica Osteonics Corp. | HRS |
| Feb 29, 2008 | K073228 | DC ULNAR SHORTENING SYSTEM Orthopro, LLC | HRS |
| Feb 27, 2008 | K080295 | CHARLOTTE CLAW 3.5 Wrightmedicaltechnologyinc | HRS |
| Feb 21, 2008 | K073460 | SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES Synthes (Usa) | HRS |
| Feb 21, 2008 | K073375 | NEWDEAL TIBIAXYS SYSTEM Newdeal Sas | HRS |
| Feb 21, 2008 | K071809 | ENSPLINTRX BONE FIXATION SYSTEM Sonoma Orthopedic Products, Inc. | HRS |
| Feb 19, 2008 | K073344 | ORTHOPEDIATRICS PLATING SYSTEM Orthopediatrics, LLC | HRS |
| Jan 7, 2008 | K073535 | BIOFOAM BONE WEDGE Wrightmedicaltechnologyinc | HRS |
| Dec 17, 2007 | K073186 | SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM Synthes (Usa) | HRS |
| Dec 14, 2007 | K072832 | ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM DePuy Orthopaedics, Inc. | HRS |
| Nov 19, 2007 | K072818 | PERI-LOC PERIARTRICULAR LCK PIT SYS-PROX FEM PLATES/SCREWS.CALBE ACCESS Smith & Nephew, Inc. | HRS |
| Nov 19, 2007 | K072740 | MONDEAL EXTREMITY BONE FIXATION SYSTEM Mondeal Medical Systems GmbH | HRS |
| Nov 7, 2007 | K072423 | 4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY. DePuy Orthopaedics, Inc. | HRS |
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