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 |
|---|---|---|---|
| Jan 28, 2014 | K133541 | EMERGE MEDICAL SMALL AND LARGE NON-LOCKING FRAGMENT PLATE SYSTEM Emerge Medical | HRS |
| Jan 23, 2014 | K133675 | AAP LOQTEQ DISTAL ANTEROLATERAL TIBIA PLATE 3.5 Aap Implantate AG, DE | HRS |
| Jan 17, 2014 | K130614 | BONE FRAGMENT AND FIXATION PLATES, SCREWS AND WASHERS Laura Cattabriga | HRS |
| Jan 8, 2014 | K133452 | EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM Emerge Medical | HRS |
| Jan 7, 2014 | K132296 | D-RAD SMART PACK Smith & Nephew, Inc. | HRS |
| Jan 6, 2014 | K132769 | ACUMED HAND PLATING SYSTEM Acumed, LLC | HRS |
| Dec 24, 2013 | K132787 | LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE Aap Implantate AG, DE | HRS |
| Dec 18, 2013 | K132876 | ARIX HAND LOCKING SYSTEM Jeil Medical Corporation, KR | HRS |
| Dec 17, 2013 | K133246 | ZIMMER DISTAL RADIUS PLATING SYSTEM Zimmer, Inc. | HRS |
| Dec 13, 2013 | K132594 | CROSSCHECK PLATING SYSTEM Solana Surgical, LLC | HRS |
| Dec 2, 2013 | K133437 | 1ST MTP PLATE Osteomed | HRS |
| Nov 19, 2013 | K132898 | A.L.P.S. CALCANEAL PLATING SYSTEM Biomet Manufacturing Corp | HRS |
| Nov 18, 2013 | K133102 | FLOWER ANKLE PLATING SET Flower Orthopedics Corporation | HRS |
| Nov 18, 2013 | K131782 | LOQTEQ HIGH TIBIA OSTEOTOMY PLATE 4.5 Aap Implantate AG, DE | HRS |
| Nov 4, 2013 | K131834 | WOLF LONG BONE PLATE SYSTEM Toby Orthopaedics | HRS |
| Nov 4, 2013 | K131566 | ARIX HAND SYSTEM Jeil Medical Corporation, KR | HRS |
| Oct 29, 2013 | K131867 | 2.5MM INLINE FUSION PLATE Biomet, Inc. | HRS |
| Oct 23, 2013 | K132502 | VARIAX 2 SYSTEM Stryker Trauma AG | HRS |
| Oct 8, 2013 | K131186 | SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM Synthes (USA) Products, LLC | HRS |
| Oct 3, 2013 | K132642 | LOCKING PLATE SYSTEM Beijing Libeier Bio-Engineering Institute Co., Ltd., CN | HRS |
| Oct 3, 2013 | K132554 | AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5 Aap Implantate AG, DE | HRS |
| Sep 25, 2013 | K130510 | ARTHREX COMPRESSION PLATES Arthrex, Inc. | HRS |
| Sep 17, 2013 | K132591 | MAXLOCK EXTREME SYSTEM Orthohelix Surgical Designs, Inc. | HRS |
| Sep 5, 2013 | K131764 | ACUMED WRIST SPANNING PLATE Acumed, LLC | HRS |
| Sep 5, 2013 | K131311 | ARIX FOOT SYSTEM Jeil Medical Corporation, KR | HRS |
| Aug 22, 2013 | K131657 | FLOWER SMALL AND MEDIUM IMPLANT SET Flower Orthopedics Corporation | HRS |
| Aug 9, 2013 | K132226 | METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT Merete Medical GmbH, DE | HRS |
| Aug 8, 2013 | K131759 | METALLIC LOCKING COMPRESSION BONE PLATES AND SCREWS SYSTEM Tianjin Walkman Biomaterial Co., Ltd., CN | HRS |
| Aug 7, 2013 | K131722 | I.T.S. EXTREMITY FIXATION SYSTEMS I.T.S. GmbH | HRS |
| Aug 7, 2013 | K131360 | INTEGRA TITANIUM BONE WEDGE Ascension Orthopedic | HRS |
| Aug 2, 2013 | K123347 | NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0 Normed Medizin-Technik GmbH | HRS |
| Jul 19, 2013 | K130731 | STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW Stabiliz Orthopaedics, LLC | HRS |
| Jul 3, 2013 | K131670 | LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT) Biomet, Inc. | HRS |
| Jul 3, 2013 | K131480 | EMERGE MEDICAL LOCKING ONE-THIRD TUBULAR PLATE SYSTEM Emerge Medical | HRS |
| Jul 3, 2013 | K131474 | ARTHREX DISTAL RADIUS PLATE SYSTEM Arthrex, Inc. | HRS |
| Jun 25, 2013 | K130008 | DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0 CANCELLOUS LOCKING SCREW, 3.0 CORTICAL LOCKING I.T.S. GmbH | HRS |
| Jun 19, 2013 | K130774 | UNIVERSAL DISTAL RADIUS SYSTEM Newclip Technics | HRS |
| Jun 18, 2013 | K131445 | OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM Osteomed LP | HRS |
| Jun 10, 2013 | K131380 | ACUMED TOTALW RIST FUSION PLATING SYSTEM Acumed, LLC | HRS |
| Jun 7, 2013 | K130185 | 4WEB OSTEOTOMY BONE WEDGE 4-Web, Inc. | HRS |
| May 31, 2013 | K131132 | PELVIS II IMPLANT SYSTEM Stryker Trauma AG | HRS |
| May 21, 2013 | K131093 | ORTHOLOC(R) 3DI ANKLE PLATING SYSTEM Wrightmedicaltechnologyinc | HRS |
| May 8, 2013 | K130964 | GRIDLOCK PLATING SYSTEM Trilliant Surgical, Ltd. | HRS |
| Apr 19, 2013 | K130108 | DOUBLE ENGINE BONE PLATE AND SCREW SYSTEMS Xiamen Double Engine Medical Material Co., Ltd., CN | HRS |
| Apr 5, 2013 | K130340 | LOCKING BONE PLATES AND SCREWS Weigao Orthopaedic Device Co., Ltd., CN | HRS |
| Apr 5, 2013 | K123241 | ARTHREX FRACTURE PLATES Arthrex, Inc. | HRS |
| Mar 29, 2013 | K123562 | FLOWER SMALL AND MEDIUM BONE IMPLANTS Flower Orthopedics Corporation | HRS |
| Mar 28, 2013 | K123964 | AXSOS 3 TI LOCKING PLATE SYSTEM Stryker Trauma AG | HRS |
| Mar 28, 2013 | K122770 | BIOMET RECONSTRUCTIVE WEDGES MODEL 110003660-99, 110003797-831 Biomet Manufacturing Corp | HRS |
| Mar 22, 2013 | K130009 | VARIAX 2 COMPRESSION PLATING SYSTEM Stryker Trauma AG | HRS |
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