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
Jun 24, 2015K151178VariAx 2 Wrist Fusion System
Stryker Trauma AG, DE
HRS
Jun 9, 2015K142906APTUS Wrist 2.5 System
Medartis AG, CH
HRS
Jun 5, 2015K143002Metallic Locking Bone Plate and Screw System
Changzhou Dingjian Medical Appliance Co., Ltd., CN
HRS
May 29, 2015K143496Piccolo Composite Plate System
CarboFix Orthopedics , Ltd., IL
HRS
May 20, 2015K142724BIOFOAM Bone Wedge
Wrightmedicaltechnologyinc
HRS
May 12, 2015K150675Dorsal Spanning Plate
Skeletal Dynamics, LLC
HRS
Apr 30, 2015K150649G3 Active Plate Large Fragment System
Genesis Fracture Care, Inc.
HRS
Apr 29, 2015K150520DARCO Locking Bone Plate System
Wrightmedicaltechnologyinc
HRS
Apr 29, 2015K150456Arthrex Plates, Screws, and Staples
Arthrex, Inc.
HRS
Apr 9, 2015K142581APTUS Foot System
Medartis AG, CH
HRS
Apr 6, 2015K143523Airlock osteosynthesis plate system
Novastep, FR
HRS
Apr 6, 2015K143385Acumed Ankle Plating System
Acumed, LLC
HRS
Apr 3, 2015K143749Arthrex Distal Radius System
Arthrex, Inc.
HRS
Mar 30, 2015K143697Biomet Proximal Humerus Plating System
Biomet Manufacturing
HRS
Mar 30, 2015K143365Eminent Foot Plate System
Eminent Spine
HRS
Mar 30, 2015K141527DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM
Synthes USA
HRS
Mar 24, 2015K150368Tarsa-Link Wedge Fixation System
Life Spine
HRS
Mar 23, 2015K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)
Synthes (USA) Products, LLC
HRS
Mar 20, 2015K141493PROXIMAL HUMERUS PLATING SYSTEM
Miami Device Solutions
HRS
Mar 19, 2015K143717Treace Medical Concepts(TMC) Plating System
Treace Medical Concepts, Inc.
HRS
Mar 4, 2015K143331Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS
Zimmer, Inc.
HRS
Mar 3, 2015K141825IDEAL Locking Plate System
Jiangsu Ideal Medical Science & Technology Co., LT, CN
HRS
Feb 25, 2015K150009Baide
Jiangsu Baide Medical Intrument Co., Ltd., CN
HRS
Feb 25, 2015K142823Biomet Microfixation Thoracic Fixation System
Biomet Microfixation
HRS
Feb 23, 2015K150121Zimmer Periarticular Plating System
Zimmer, Inc.
HRS
Jan 30, 2015K141548HIGH TIBIAL OSTEOTOMY SYSTEM
Newclip Technics
HRS
Jan 26, 2015K143061Activ Ankle Locking Plating System
Newclip Technics, FR
HRS
Jan 23, 2015K143394Acumed Small Fragment Base Set
Acumed, LLC
HRS
Jan 16, 2015K143139Arthrex Fracture System
Arthrex, Inc.
HRS
Jan 16, 2015K143023Nitinol Compression Plating System
Biomedical Enterprises, Inc.
HRS
Dec 23, 2014K142502ALIANS ULNA LOCKING PLATING SYSTEM
Newclip Technics, FR
HRS
Dec 22, 2014K143138AxSOS 3 Ti Locking Plate System
Stryker Trauma AG
HRS
Dec 18, 2014K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws
Smith & Nephew, Inc.
HRS
Dec 16, 2014K142419Mini and Micro Fragments Reconstruction System-NEOFIX
Neoortho Productos Orthopedicos S/A, BR
HRS
Dec 5, 2014K143025TOTAL COMPRESSION PLATING SYSTEM
Wrightmedicaltechnologyinc
HRS
Nov 28, 2014K143066Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws and Washers
Zimmer, Inc.
HRS
Nov 26, 2014K142938G3 Active Plate Large Fragment System
Genesis Fracture Care, Inc.
HRS
Nov 12, 2014K142836Zimmer Plates and Screws (ZPS), Forte Screws
Zimmer, Inc.
HRS
Oct 31, 2014K142484Sternal Closure System
Jace Medical, LLC
HRS
Oct 22, 2014K142579Zimmer Periarticular Plating System
Zimmer, Inc.
HRS
Sep 26, 2014K142418I.T.S. Hand Locking Plates System - HLS
I.T.S. GmbH, AT
HRS
Sep 26, 2014K141905PRO-LINK WEDGE SYSTEM
Life Spine
HRS
Sep 15, 2014K142306Flower Upper Extremity Plating Set
Flower Orthopedics Corporation
HRS
Aug 29, 2014K141796DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM
Synthes (USA) Products, LLC
HRS
Aug 28, 2014K142135REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION
Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic
HRS
Aug 28, 2014K140892DISTAL ELBOW PLATING SYSTEM
Skeletal Dynamics, LLC
HRS
Aug 21, 2014K142121VALOR HINDFOOT FUSION NAIL SYSTEM
Wrightmedicaltechnologyinc
HRS
Aug 15, 2014K141735ARTHREX ANKLE FUSION PLATING SYSTEM
Arthrex, Inc.
HRS
Aug 14, 2014K140508ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWS
Zimmer, Inc.
HRS
Aug 13, 2014K141734ZIMMER PERIARTICULAR LOCKING SYSTEM
Zimmer, Inc.
HRS

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