ClearanceBrief
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)
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Top companies in HRS

Company510(k)sRecalls
Synthes1048
Smith & Nephew3716
Biomet2128
Wrightmedicaltechnologyinc450
Zimmer GmbH3212
Arthrex, Inc.403
Wright Medical Technology Inc043
DePuy Orthopaedics, Inc.1814
Medartis AG320
TriMed, Inc.256
Decided510(k)Device and applicantCode
Aug 13, 2014K141517ZIMMER PLATES AND SCREWS (ZPS)-NON-STERILE PLATES
Zimmer, Inc.
HRS
Aug 7, 2014K141992VARIAX 2 SYSTEM
Stryker Trauma AG
HRS
Aug 7, 2014K141823AAP LOQTEC CLAVICLE PLATES 2.7/3.5
Aap Implantate AG, DE
HRS
Aug 7, 2014K141241MATRIXRIB ENDO THORACOSCOPIC RIB PLATING SYSTEM
Synthes (USA) Products, LLC
HRS
Jul 29, 2014K140431PEDILOC FRAGMENT SYSTEM
OrthoPediatrics Corp.
HRS
Jul 29, 2014K133840Kangli Locking Plate System
Suzhou Kangli Orthopaedics Instrument Co., Ltd., CN
HRS
Jul 24, 2014K141489LINOS MOH HAND PLATING SYSTEM
KLS Martin L.P.
HRS
Jul 23, 2014K141784ORTHO SOLUTIONS ULTOS PLATING SYSTEM
Ortho Solutions Limited
HRS
Jul 22, 2014K141677VARIAX ELBOW PLATING SYSTEM
Stryker Trauma AG
HRS
Jul 22, 2014K140876VIEW PLATING SYSTEM,REDUCE FRACTURE PLATING SYSTEM,BONE SCREW
Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic
HRS
Jul 18, 2014K141430VARIAX DISTAL RADIUS PLATING SYSTEM
Stryker Leibinger GmbH & Co KG
HRS
Jul 11, 2014K141301MAXLOCK EXTREME ELBOW FRACTURE SYSTEM
Orthohelix Surgical Designs, Inc.
HRS
Jul 9, 2014K141417CHARLOTTE (TM) MTP BONE FUSION PLATE SYSTEM HEX SCREW
Wrightmedicaltechnologyinc
HRS
Jul 9, 2014K140531BIOFOAM BONE WEDGE
Wrightmedicaltechnologyinc
HRS
Jul 8, 2014K141478ARTHREX FRACTURE PLATES AND SCREWS
Arthrex, Inc.
HRS
Jun 30, 2014K141045MBD PLATE SYSTEM
Mbd Medical, LLC
HRS
Jun 23, 2014K141232APTUS ULNA SHORTENING 2.5
Medartis AG
HRS
Jun 20, 2014K141204VARIAX 2 ONE THIRD TUBULAR PLATING SYSTEM
Stryker Trauma AG
HRS
Jun 20, 2014K141121AXSOS 3 TI LOCKING PLATE SYSTEM
Stryker Trauma AG
HRS
Jun 13, 2014K141383ACUMED HAND FRACTURE SYSTEM
Acumed, LLC
HRS
Jun 9, 2014K140357OIC VARIABLE ANGLE SMALL FRAGMENT LOCKING PLATE SYSTEM
Orthopaedic Implant Company
HRS
Jun 3, 2014K140226OTIS-C-PLUS, NEOTIS PLATE, SCREW 06.5
Science For Biomaterials, FR
HRS
May 29, 2014K140565VARIAX 2 COMPRESSION PLATING SYSTEM
Stryker Trauma AG
HRS
May 22, 2014K140792SALVATION 3DI PLATING SYSTEM
Wrightmedicaltechnologyinc
HRS
May 14, 2014K140724MSP METATARSAL SHORTENING SYSTEM
Nextremity Solutions, Inc.
HRS
May 13, 2014K140622DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE
Biomet, Inc.
HRS
May 8, 2014K140607AAP LOQTEC(R) OLECRANON PLATE
Aap Implantate AG, DE
HRS
May 7, 2014K140814EVOS MINI-FRAGMENT PLATING SYSTEM
Smith & Nephew, Inc.
HRS
May 2, 2014K133616MATRIXRIB FIXATION SYSTEM
Synthes (USA) Products, LLC
HRS
May 1, 2014K140216ORTHOPEDIC FIXATION SYSTEMS
Impact Medical, LLC
HRS
Apr 25, 2014K140617PINIT SMALL BONE FUSION SYSTEM
Arthrosurface, Inc.
HRS
Apr 17, 2014K140769VARIAX 2 SYSTEM
Stryker Trauma AG
HRS
Apr 17, 2014K140397PARALOCK PLATING SYSTEM / TUFFNEK SCREW
Paragon 28
HRS
Apr 7, 2014K140372FRAGMENT PLATE SYSTEM
Skeletal Dynamics, LLC
HRS
Apr 7, 2014K140069LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0
Merete Medical GmbH, DE
HRS
Apr 3, 2014K140376VARIAX 2 SYSTEM
Stryker Trauma AG
HRS
Apr 1, 2014K140259VARIAX CLAVICLE HOOK PLATE
Stryker Trauma AG
HRS
Apr 1, 2014K133939MODIFIED DISTAL RADIUS PLATING SYSTEM
Biomet
HRS
Mar 27, 2014K133930FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET
Flower Orthopedics Corporation
HRS
Mar 24, 2014K133974VARIAX DISTAL RADIUS PLATING SYSTEM
Stryker Leibinger GmbH
HRS
Mar 13, 2014K140107EMERGE MEDICAL DISTAL RADIUS SET
Emerge Medical
HRS
Mar 12, 2014K140119EMERGE MEDICAL PERIARTICULAR AND LOCKING LARGE FRAGMENT SYSTEM
Emerge Medical
HRS
Mar 12, 2014K140098EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM
Emerge Medical
HRS
Mar 4, 2014K133525LOCKING COMPRESSION BONE PLATES AND SCREW SYSTEM
Changzhou Dean Medical Instrument Co, Ltd., CN
HRS
Mar 3, 2014K133668AFT GREATER TUBEROSITY FRACTURE PLATE, LEFT, AFT GREATER TUBEROSITY FRACTURE PLATE, RIGHT, AFT GREATER TUBEROSITY CANNUL
Shoulder Options, Inc.
HRS
Feb 28, 2014K133715CHARLOTTE CLAW PLATE SYSTEM
Wrightmedicaltechnologyinc
HRS
Feb 26, 2014K133536EMERGE MEDICAL BONE PLATE SYSTEM
Emerge Medical
HRS
Feb 24, 2014K133691EXTRIMILOCK ANKLE PLATING SYSTEM
Osteomed LP
HRS
Feb 12, 2014K131552CONVENTUS DRS
Conventus Orthopaedics
HRS
Feb 4, 2014K132886SMITH & NEPHEW VARIABLE-ANGLE LOCKING MINI-FRAGMENT PLATING SYSTEM
Smith & Nephew, Inc.
HRS

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