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
Aug 24, 2018K181035AOS Small Fragment Plating System Lite
Advanced Orthopaedic Solutions, Inc. (Aos)
HRS
Aug 24, 2018K181009APTUS CMC-I Fusion Plate System
Medartis AG, CH
HRS
Aug 9, 2018K181533EVOS Wrist Fracture Plating System
Smith & Nephew, Inc.
HRS
Aug 5, 2018K181425APTUS® Proximal Humerus System
Medartis AG, CH
HRS
Aug 2, 2018K180150PL8 Wrist Reconstruction Plate
Citieffe S.R.L., IT
HRS
Jun 15, 2018K181113CoLink™ Afx Plating System
In2bones USA, LLC
HRS
May 23, 2018K181067AlignX Ankle Fusion System
Extremity Medical, LLC
HRS
May 22, 2018K180808Omni Foot Plating System
Extremity Medical, LLC
HRS
May 16, 2018K180239Additive Orthopaedics Patient Specific 3D Printed Bone Segments
Additive Orthopaedics, LLC
HRS
May 8, 2018K171690Trident Extremity Fixation System
Trident Orthopedics
HRS
Apr 6, 2018K173767A. L. P. S. Clavicle Plating System
Biomet, Inc.
HRS
Mar 29, 2018K171624IXOS Radius Plate System
Stuckenbrock Medizintechnik GmbH, DE
HRS
Mar 19, 2018K173930PYTHON Plate Trial Instruments
Treace Medical Concepts, Inc.
HRS
Mar 19, 2018K172148Anchorage Bone Plating System
Stryker GmbH
HRS
Mar 15, 2018K171808TDM Plate and Screw System
Tdm Co., Ltd., KR
HRS
Mar 8, 2018K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & M
Meril Healthcare Pvt. , Ltd., IN
HRS
Feb 27, 2018K173746Activmotion Range
Newclip Technics, FR
HRS
Feb 22, 2018K172294Osteotomy Truss System (OTS)
4Web, Inc.
HRS
Jan 16, 2018K173641Activ Ankle
Newclip Technics, FR
HRS
Jan 8, 2018K173293EVOS Small Fragment Upper Extremity Plates
Smith & Nephew, Inc.
HRS
Jan 4, 2018K171372Alians Elbow Locking Plating System
Newclip Technics, FR
HRS
Dec 21, 2017K172973Life Spine Foot and Ankle Plating System
Life Spine, Inc.
HRS
Dec 20, 2017K172886Breakaway Screw System
Paragon 28
HRS
Dec 15, 2017K172350AxSOS 3 Ti
Stryker GmbH, CH
HRS
Dec 8, 2017K172786MDS Plating System
Miami Device Solutions, LLC
HRS
Dec 6, 2017K172425OrthoPediatrics Wrist Fusion Plate
Orthopediatrics, Inc.
HRS
Dec 1, 2017K172008ARIX Humerus System
Jeil Medical Corporation, KR
HRS
Nov 28, 2017K173121Ankle Fusion Plating System
In2bones Sas, FR
HRS
Nov 27, 2017K172300CoLink View Plating System
In2bones USA, LLC
HRS
Nov 16, 2017K172178Minimally Invasive Bunion Plating System
Trilliant Surgical, Ltd.
HRS
Nov 13, 2017K173166ANTHEM Fracture System
Globus Medical, Inc.
HRS
Nov 6, 2017K172441EPIC Extremity Fracture Plate System
Epic Extremity, LLC
HRS
Nov 6, 2017K172260Omni Foot Plating System
Extremity Medical, LLC
HRS
Oct 23, 2017K171293G3™ Active Plate® Miniature System
Genesis Fracture Care, Inc.
HRS
Sep 21, 2017K171852DARCO Locking Bone Plate System
Wrightmedicaltechnologyinc
HRS
Sep 21, 2017K170705ARIX Wrist System
Jeil Medical Corporation, KR
HRS
Sep 8, 2017K172170APTUS(R) Wrist 2.5 System
Medartis AG, CH
HRS
Sep 8, 2017K171510Footmotion Plating System
Newclip Technics, FR
HRS
Sep 1, 2017K170547Arthrex Mesh Plate System
Arthrex, Inc.
HRS
Aug 24, 2017K171173OrthoPediatrics Titanium PediPlates® System
OrthoPediatrics Corp.
HRS
Aug 23, 2017K172262EVOS Small Fragment Plating System
Smith & Nephew, Inc.
HRS
Aug 17, 2017K170979ARIX Ankle Fibula Hook Plate System
Jeil Medical Corporation, KR
HRS
Aug 14, 2017K170780ARIX Foot System (2.3/2.8)
Jeil Medical Corporation, KR
HRS
Aug 3, 2017K162507Arzzt 3.5 / 4.5 Small & Large Fragments System
Truemed Group, LLC
HRS
Jul 27, 2017K170313ARIX Ankle Distal Tibia System
Jeil Medical Corporation, KR
HRS
Jul 24, 2017K171285ARIX Diaphysis System
Jeil Medical Corporation, KR
HRS
Jul 14, 2017K170518In2Bones Fracture and Correction System
In2bones USA, LLC
HRS
Jun 30, 2017K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) – MR Conditional
Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.
HRS
Jun 27, 2017K171590Distal Elbow Plating System
Skeletal Dynamics, LLC
HRS
Jun 22, 2017K170727VariAx 2 Compression Plating System
Stryker GmbH
HRS

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