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 27, 2017K171590Distal Elbow Plating System
Skeletal Dynamics, LLC
HRS
Jun 22, 2017K170727VariAx 2 Compression Plating System
Stryker GmbH
HRS
Jun 20, 2017K163593Additive Orthopaedics Bunion System
Additive Orthopaedics, LLC
HRS
Jun 16, 2017K170843Alians Fragment Specific
Newclip Technics, FR
HRS
Jun 16, 2017K162674BioPro Foot Plating Systems
Biopro, Inc.
HRS
Jun 14, 2017K170457EVOS Small Fragment Lower Extremity Plates
Smith & Nephew, Inc.
HRS
May 12, 2017K170401Piccolo Composite® Plate System
CarboFix Orthopedics , Ltd., IL
HRS
May 8, 2017K170771VariAx 2 Foot System
Stryker GmbH
HRS
May 5, 2017K163293Colink™ Plating System
In2bones USA, LLC
HRS
May 2, 2017K162380Locking Plate System
Beijing Keyi Medical Device Technology Co., Ltd., CN
HRS
Apr 24, 2017K170887EVOS Small Fragment Plating System
Smith & Nephew, Inc.
HRS
Apr 24, 2017K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension
Wrightmedicaltechnologyinc
HRS
Apr 24, 2017K162154Pantheon Medical Balanced Plating System
Pantheon Medical
HRS
Apr 19, 2017K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Pl
Greens Surgicals Pvt. , Ltd., IN
HRS
Apr 13, 2017K170214Additive Orthopaedics Locking Lattice Plate
Additive Orthopaedics, LLC
HRS
Apr 7, 2017K163361ANTHEM™ Fracture System
Globus Medical, Inc.
HRS
Mar 30, 2017K170310Alians Clavicle range
Newclip Technics, FR
HRS
Mar 24, 2017K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System
Narang Medical USA Corporation
HRS
Mar 17, 2017K162898Olecranon Plating System
Miami Device Solutions, LLC
HRS
Mar 16, 2017K163003Y3 Proximal Femoral Plate System
Pega Medical, Inc., CA
HRS
Mar 13, 2017K163039ORTHOLOC® 3Di Small Bones Plating
Wrightmedicaltechnologyinc
HRS
Mar 9, 2017K170124Level One Hand Plating System
KLS Martin L.P.
HRS
Feb 21, 2017K162841VariAx Distal Radius Plating System, VariAx 2 System
Stryker GmbH
HRS
Feb 21, 2017K162391AlignMATE™ Lapidus Arthrodesis System
Arthrosurface, Inc.
HRS
Feb 9, 2017K163046DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long
DePuy Synthes
HRS
Feb 9, 2017K161861APTUS® Coronoid 2.0
Medartis AG, CH
HRS
Feb 3, 2017K162439AxSOS 3 Ti; Stryker Plating System
Stryker GmbH
HRS
Jan 26, 2017K163044ORTHOLOC® 3Di Ankle Fracture Plating System
Wrightmedicaltechnologyinc
HRS
Jan 26, 2017K161303dynaMX™ Compression Plate
Mx Orthopedics, Corp.
HRS
Jan 10, 2017K162179osteo-WEDGE II ® Open Wedge Bone Locking Plate System
Graham Medical Technologies, LLC Dba Gramedica
HRS
Dec 21, 2016K163086VLP MINI-MOD 2.0mm Column Plates
Smith & Nephew, Inc.
HRS
Dec 9, 2016K162974Biomet Microfixation RibFix Blu Thoracic Fixation System
Biomet Microfixation
HRS
Dec 9, 2016K162829Medline UNITE® Ankle Fracture Plating System
Medline Industries, Inc.
HRS
Nov 23, 2016K163007Biomet Microfixation SternaLock 360 Sternal Closure System
Biomet Microfixation
HRS
Nov 23, 2016K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5
Aap Implantate AG, DE
HRS
Nov 22, 2016K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Pl
Aap Implantate AG, DE
HRS
Nov 18, 2016K162078EVOS Small Fragment Plating System
Smith & Nephew, Inc.
HRS
Nov 15, 2016K161665VLP Wrist Fracture System
Smith & Nephew, Inc.
HRS
Nov 4, 2016K161913AOS Small Fragment Plating System
Advanced Orthopaedic Solutions, Inc. (Aos)
HRS
Nov 4, 2016K161703LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer
Aap Implantate AG, DE
HRS
Nov 3, 2016K161590MatrixRIB Fixation System
Synthes (USA) Products, LLC
HRS
Oct 31, 2016K161448Footmotion Plating System
Newclip Technics, FR
HRS
Oct 21, 2016K162635Distal Radius Plating System
Miami Device Solutions, LLC
HRS
Oct 12, 2016K162424Ulna Plating System
Biomet, Inc.
HRS
Sep 27, 2016K162307OrthoPediatrics Locking Proximal Femur System Cortical Screws
OrthoPediatrics Corp.
HRS
Sep 21, 2016K161746ARIX Hand System
Jeil Medical Corporation, KR
HRS
Sep 7, 2016K153207Additive Orthopaedics Bone Wedge System
Additive Orthopaedics, LLC
HRS
Aug 17, 2016K152289Alians Elbow Locking Plating System
Newclip Technics, FR
HRS
Aug 15, 2016K161292Distal Radius Plating System
Miami Device Solutions, LLC
HRS
Aug 15, 2016K161037Tarsa-Link Stand-Alone Wedge Fixation System
Life Spine, Inc.
HRS

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