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 |
|---|---|---|---|
| Jun 17, 2011 | K111086 | ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM OrthoPediatrics Corp. | HRS |
| Jun 6, 2011 | K111041 | MINI VARIABLE SYSTEM Orthohelix Surgical Designs, Inc. | HRS |
| May 19, 2011 | K111039 | ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM Zimmer, Inc. | HRS |
| May 18, 2011 | K110574 | BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM Biomet Microfixation, Inc. | HRS |
| May 13, 2011 | K102845 | MAHE FIXATION PLATE AND SCREW SYSTEM Mahe Medical GmbH, GR | HRS |
| Apr 21, 2011 | K110125 | 2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM Synthes USA | HRS |
| Apr 14, 2011 | K093914 | NEWDEAL COMPRESSION PLATES Newdeal Sas | HRS |
| Mar 18, 2011 | K110476 | AXSOS (TM) LOCKING PLATE SYSTEM Stryker Corp. | HRS |
| Mar 15, 2011 | K101930 | MEMOMETAL NAVIS BONE PLATING SYSTEM Memometal Technologies, FR | HRS |
| Feb 24, 2011 | K102597 | PICCOLO COMPOSITE PLATE SYSTEM N.M.B. Medical Applications, Ltd., IL | HRS |
| Feb 15, 2011 | K110176 | AXSOS LOCKED PLATING 4.0MM LOCKING INSERTS Howmedica Osteonics Corp., Dba Stryker Orthopaedics | HRS |
| Jan 24, 2011 | K103332 | APTUS ULNA PLATES Medartis AG | HRS |
| Jan 21, 2011 | K103243 | 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM Synthes (Usa) | HRS |
| Jan 4, 2011 | K102998 | CONGRUENT BONE PLATE SYSTEM Acumed, LLC | HRS |
| Dec 16, 2010 | K103408 | POSTERIOR LATERAL PLATES DePuy Orthopaedics, Inc. | HRS |
| Dec 15, 2010 | K102201 | CONTOURS LAPIDUS PLATING SYSTEM Orthofix, Inc. | HRS |
| Dec 10, 2010 | K102537 | APTUS 1.5 TRILOCK Medartis AG | HRS |
| Dec 9, 2010 | K102694 | 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES Synthes (Usa) | HRS |
| Dec 7, 2010 | K102282 | THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES Howmedica Osteonics Corp., Dba Stryker Orthopaedics | HRS |
| Dec 7, 2010 | K102095 | SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM Suspension Orthopaedic Solutions, LLC | HRS |
| Dec 2, 2010 | K102352 | EVOLVE EPS ORTHOLOC Wrightmedicaltechnologyinc | HRS |
| Nov 24, 2010 | K102505 | HTO PLATING SYSTEM Aesculap Implant Systems, LLC | HRS |
| Nov 23, 2010 | K102429 | ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREW Wrightmedicaltechnologyinc | HRS |
| Nov 9, 2010 | K101400 | LOCKING COMPRESSION PLATE Changzhou Orthmed Medical Instrument Co., Ltd., CN | HRS |
| Oct 22, 2010 | K100944 | CLAVICLE LOCKING PLATE SYSTEM Newclip Technics | HRS |
| Oct 20, 2010 | K101936 | CONTOURS VSP III VOLAR PLATING SYSTEM Orthofix, Inc. | HRS |
| Oct 6, 2010 | K100123 | ACUMED WRIST ARTHRODESIS PLATE SYSTEM Acumed, LLC | HRS |
| Sep 30, 2010 | K102156 | MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWS Orthohelix Surgical Designs, Inc. | HRS |
| Sep 27, 2010 | K101962 | MINI MAXLOCK EXTREME PLATING SYSTEM Orthohelix Surgical Designs, Inc. | HRS |
| Sep 15, 2010 | K101536 | 2.7/3.5MM VA-LCP ANTERIRO CLAVICLE PLATE SYSTEM Synthes (Usa), LLC | HRS |
| Aug 5, 2010 | K093868 | I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM I.T.S. Implantat-Technologie-Systeme GmbH | HRS |
| Aug 3, 2010 | K100776 | SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM Synthes (Usa) | HRS |
| Aug 2, 2010 | K100502 | ASCENSION TOTAL PLATE SYSTEM Ascension Orthopedics, Inc. | HRS |
| Jul 23, 2010 | K101240 | CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467 DePuy Orthopaedics, Inc. | HRS |
| Jun 25, 2010 | K092889 | SYNTEC OSTEO-PLATE AND SCREW FIXATION Syntec Scientific Corp., TW | HRS |
| Jun 16, 2010 | K100176 | ASCENSION ANKLE FUSION PLATE SYSTEM Ascension Orthopedics, Inc. | HRS |
| Jun 15, 2010 | K101421 | MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708; 851318704-708, 131218204 DePuy Orthopaedics, Inc. | HRS |
| Jun 14, 2010 | K100604 | OTIS -C PLUS Sciences ET Bio Materiaux (Sbm), FR | HRS |
| May 21, 2010 | K092528 | BIOMET FORERUNNER LOCKING PLATE SYSTEM Biomet Trauma (Aka Ebi, Lp) | HRS |
| May 17, 2010 | K100240 | ORTHOPEDIATRICS PEDILOC TIBIA PLATE SYSTEM OrthoPediatrics Corp. | HRS |
| May 14, 2010 | K100271 | VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES Howmedica Osteonics Corp. | HRS |
| May 13, 2010 | K101056 | VARIAX ELBOW SYSTEM Howmedica Osteonics Corp. | HRS |
| May 11, 2010 | K093978 | EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM Exactech, Inc. | HRS |
| May 11, 2010 | K092812 | SYNTHES (USA) 2.7MM/ 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATES Synthes (Usa) | HRS |
| Apr 30, 2010 | K100475 | AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 5MM LOCKING INSERTS Howmedica Osteonics Corp. | HRS |
| Apr 20, 2010 | K100618 | MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY Orthohelix Surgical Designs, Inc. | HRS |
| Apr 16, 2010 | K093880 | PEANUT GROWTH CONTROL PLATING SYSTEM Ebi, L.P. | HRS |
| Apr 12, 2010 | K100111 | NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM Zimmer, Inc. | HRS |
| Apr 12, 2010 | K090975 | DEROYAL NON-LOCKING BONE FIXATION SYSTEM Deroyal Industries, Inc. | HRS |
| Apr 8, 2010 | K100676 | SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL Synthes (Usa) | HRS |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.