ClearanceBrief
Panels › Orthopedic › Product code HRS · Class 2

Plate, Fixation, Bone

Regulation 888.3030

62510(k)s in 12 months (1,332 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
Wright Medical Technology Inc043
Arthrex, Inc.393
DePuy Orthopaedics, Inc.1814
Medartis AG320
TriMed, Inc.256
Decided510(k)Device and applicantCode
Nov 24, 2021K211650The Radian MIS Bunion System
Nvision Biomedical Technologies, Inc.
HRS
Nov 18, 2021K212640Stratum® Ankle Fusion Plating System
Nextremity Solutions, Inc.
HRS
Nov 18, 2021K212487CoLink Vallux Plating System
In2bones USA, LLC
HRS
Oct 18, 2021K211582LOQTEQ Proximal Humerus Plate 3.5 System
Aap Implantate AG, DE
HRS
Oct 5, 2021K203002SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, TAMlNA 3.5mm Proximal Humerus System,
Bonebridge AG, CH
HRS
Oct 1, 2021K212433Anthem Fracture System
Globus Medical, Inc.
HRS
Sep 21, 2021K212334GEO Extremity and Ankle Plating System
Gramercy Extremity Orthopedics, LLC
HRS
Aug 20, 2021K212297Omni Foot and Ankle Plating System
Extremity Medical, LLC
HRS
Aug 13, 2021K203817Tyber Medical Anatomical Plating System
Tyber Medical, LLC
HRS
Jul 30, 2021K203408Summit Patella Plating System
Endeavor Orthopaedics, LLC
HRS
Jul 28, 2021K211646FINE Osteotomy
Bodycad Laboratories, Inc., CA
HRS
Jul 27, 2021K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integr
Integra LifeSciences Corporation
HRS
Jul 16, 2021K211592Avanti Orthopaedics Ulnar Shortening System
Avanti Orthopaedics, Inc.
HRS
Jul 15, 2021K210750Acumed Clavicle Hook Plating System
Acumed, LLC
HRS
Jul 9, 2021K200575TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM
Truemed Group, LLC
HRS
Jun 29, 2021K210837Smith & Nephew Plates and Screws
Smith & Nephew, Inc.
HRS
Jun 23, 2021K211695Valkyrie Thoracic Fixation System
Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices
HRS
Jun 2, 2021K211051DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)
DePuy Synthes
HRS
May 6, 2021K202971DRPx Locking Distal Radius Plate System
Orthopaedic Implant Company
HRS
Apr 30, 2021K210290JACE Medical Thoracic Plating System
Jace Medical, LLC
HRS
Apr 20, 2021K210157SOLE Medial Column Fusion Plate
Orthofix Srl, IT
HRS
Apr 13, 2021K210658Volition Plating System
Ortho Solutions UK , Ltd., GB
HRS
Apr 8, 2021K210408DePuy Synthes Variable Angle Locking Patella Plating System
Synthes (USA) Products, LLC
HRS
Mar 26, 2021K210534GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
Gramercy Extremity Orthopedics, LLC
HRS
Mar 26, 2021K210205DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System
Synthes (USA) Products, LLC
HRS
Mar 25, 2021K203834Arthrex Patella SuturePlates
Arthrex, Inc.
HRS
Mar 12, 2021K210060CoLink Mfx Implant System
In2bones USA, LLC
HRS
Mar 8, 2021K201728Versalock Periprosthetic Femur Plates System-GMReis
GM Dos Reis Industria e Comercio Ltda., BR
HRS
Mar 3, 2021K210043LOQTEQ Distal Lateral Femur Plate 4.5 System
Aap Implantate AG, DE
HRS
Mar 2, 2021K202889Able Medical Devices Valkyrie Thoracic Fixation System
Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices
HRS
Feb 24, 2021K203479ExtremiLOCK Lateral Ankle Fusion Plates
Osteomed
HRS
Feb 22, 2021K200062Foot and Ankle System
Leith Medical, LLC
HRS
Feb 19, 2021K210192A.L.P.S. Clavicle Plating System
Biomet, Inc.
HRS
Feb 3, 2021K203294Arthrex Pilon Fusion System
Arthrex, Inc.
HRS
Jan 28, 2021K203474Biomet Microfixation RibFix Advantage System
Biomet Micofixation
HRS
Jan 27, 2021K203405EVOS Large Fragment Plating System
Smith & Nephew, Inc.
HRS
Jan 8, 2021K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System
Wrightmedicaltechnologyinc
HRS
Dec 29, 2020K203511Baby Gorilla/Gorilla Plating System
Paragon 28, Inc.
HRS
Dec 16, 2020K203414DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System
DePuy Synthes
HRS
Dec 14, 2020K202657Javelin Tailor's Bunion Fixation System
Nvision Biomedical Technologies, Inc.
HRS
Nov 24, 2020K202959PolyLock Plating System
Fusion Orthopedics, LLC
HRS
Nov 20, 2020K202764Ortho Solutions Plating System
Ortho Solutions UK , Ltd., GB
HRS
Nov 17, 2020K202307Activ Fuse
Newclip Technics, FR
HRS
Nov 16, 2020K201918EVOS Large Fragment Plating System
Smith & Nephew, Inc.
HRS
Oct 29, 2020K202912ARIX Ankle Distal Tibia System
Jeil Medical Corporation, KR
HRS
Oct 29, 2020K202496ANTHEM Fracture System
Globus Medical, Inc.
HRS
Oct 26, 2020K202489AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System
Advanced Orthopaedic Solutions, Inc.
HRS
Oct 13, 2020K201962Skeletal Dynamics Ulnar Shortening Plating System
Skeletal Dynamics, Inc.
HRS
Oct 8, 2020K201917Piccolo Composite Proximal Tibia Plate System
CarboFix Orthopedics , Ltd., IL
HRS
Sep 15, 2020K201656ARIX Elbow System
Jeil Medical Corporation, KR
HRS

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