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Plate, Fixation, Bone

FDA product code HRS · 1194 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3030
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-12-16 – 2026-09-23

HRS 2020-07-22

EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)

Applicant Smith & Nephew, Inc.

K number K201527

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HRS 2020-07-22

DAC Dynamic Active Compression Plate

Applicant Pioneer Surgical Technology, Inc., Dba Rti Surgical

K number K200513

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HRS 2020-07-15

CoLink Plating System

Applicant In2bones USA, LLC

K number K201149

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HRS 2020-07-08

Arthrex DynaNite Compression Plate

Applicant Arthrex, Inc.

K number K193345

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HRS 2020-07-06

Arthrex MaxForce MTP Compression Plates and Screws

Applicant Arthrex, Inc.

K number K201235

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HRS 2020-06-25

Lever Action Plate System

Applicant Mcginley Orthpaedic Innovations, LLC

K number K200834

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HRS 2020-06-05

AxSOS 3 AF System and AxSOS 3 Ti System

Applicant Stryker GmbH

K number K200398

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HRS 2020-06-01

Skeletal Dynamics Forearm Plating System

Applicant Skeletal Dynamics, Inc.

K number K200538

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HRS 2020-05-22

JPS JuniOrtho Plating System

Applicant Orthofix Srl

K number K200246

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HRS 2020-05-14

Skeletal Dynamics Midshaft Humerus Plating System

Applicant Skeletal Dynamics, Inc.

K number K200701

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HRS 2020-05-14

Distal Humerus Plating System

Applicant Skeletal Dynamics, Inc.

K number K200367

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HRS 2020-05-08

Treace Medical Concepts (TMC) Plating System

Applicant Treace Medical Concepts, Inc.

K number K200961

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HRS 2020-04-23

CoLink Cfx Plating System

Applicant In2bones USA, LLC

K number K200762

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HRS 2020-04-09

ATLAS Plating System

Applicant MiRus, LLC

K number K191867

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HRS 2020-03-26

GEO 1st MTP Joint Arthrodesis Plating System

Applicant Gramercy Extremity Orthopedics, LLC

K number K200108

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HRS 2020-03-26

APTUS® Foot 2.8-3.5 System

Applicant Medartis AG

K number K193639

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HRS 2020-03-26

APTUS® Ankle Trauma System 2.8/3.5

Applicant Medartis AG

K number K193633

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HRS 2020-03-25

FINE Osteotomy around the knee

Applicant Bodycad Laboratories, Inc.

K number K193614

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HRS 2020-03-23

Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range

Applicant Field Orthopaedics Pty, Ltd.

K number K200043

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HRS 2020-03-19

Park's Pectus System

Applicant Tdm Co., Ltd.

K number K191057

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HRS 2020-03-04

ARIX Ankle System

Applicant Jeil Medical Corporation

K number K193616

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HRS 2020-02-27

Pitkar Locked Plating System

Applicant S.H.Pitkar Orthotools Pvt. , Ltd.

K number K192619

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HRS 2020-02-16

APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System

Applicant Medartis AG

K number K193554

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HRS 2020-02-03

Comus Locking Plate systems

Applicant Jiangsu Trauhui Medical Instrument Co., Ltd.

K number K190842

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HRS 2020-01-24

APTUS Clavicle System

Applicant Medartis AG

K number K192984

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HRS 2020-01-20

Tyber Medical Anatomical Plating System

Applicant Tyber Medical, LLC

K number K193222

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HRS 2020-01-17

CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System

Applicant In2bones USA, LLC

K number K193543

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HRS 2020-01-10

MotoBAND CP Implant System

Applicant Crossroads Extemity Systems, LLC

K number K193452

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HRS 2020-01-05

TriMed ASET Foot Plating System

Applicant TriMed, Inc.

K number K192696

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HRS 2019-12-23

Mini and Micro Fragments Reconstruction System – GMReis

Applicant Gm Dos Reis Industria E Comerico Ltda.

K number K182718

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HRS 2019-12-14

Airlock Centrolock Osteosynthesis Implant System

Applicant Novastep

K number K192356

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HRS 2019-12-13

Avanti Distal Radius and Forearm System

Applicant Avanti Orthopaedics, Inc.

K number K191118

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HRS 2019-12-09

Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System

Applicant Nebula Surgical Private Limited

K number K191793

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HRS 2019-12-03

Exsomed Wrist Plating System

Applicant Exsomed Corporation

K number K192473

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HRS 2019-11-22

VariAx Foot

Applicant Stryker GmbH

K number K192675

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HRS 2019-11-21

Axis Plating System

Applicant Extremity Medical, LLC

K number K192592

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HRS 2019-11-18

PolyLock Small Bone Plating System

Applicant Fusion Orthopedics, LLC

K number K192323

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HRS 2019-11-15

TDM Plate and Screw Systems

Applicant Tdm Co., Ltd.

K number K190391

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HRS 2019-11-12

ARIX Wrist System

Applicant Jeil Medical Corporation

K number K191972

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HRS 2019-11-08

APTUS Wrist Arthrodesis Plates

Applicant Medartis AG

K number K192297

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HRS 2019-11-07

DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile

Applicant Synthes (USA) Products, LLC

K number K192327

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HRS 2019-10-30

Treace Medical Concepts (TMC) Plating System

Applicant Treace Medical Concepts, Inc.

K number K192504

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HRS 2019-10-16

Arthrex Minimally Invasive Ankle Fusion Plate

Applicant Arthrex, Inc.

K number K190953

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HRS 2019-10-15

Arthrex Mini Comprehensive Fixation System – 1.4mm & 1.6mm Module

Applicant Arthrex, Inc.

K number K191326

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HRS 2019-10-03

Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module

Applicant Arthrex, Inc.

K number K191344

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HRS 2019-09-30

APTUS Wrist Spanning Plates 2.5

Applicant Medartis AG

K number K191848

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HRS 2019-09-16

AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius Screws

Applicant Industrias Medicas Sampedro S.A.S

K number K191641

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HRS 2019-09-13

NCB Plating System Distal Femur and Proximal Tibia

Applicant Zimmer GmbH

K number K192217

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HRS 2019-08-23

VariAx 2 System, VariAx 2 Mini Fragment System

Applicant Stryker GmbH

K number K191412

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HRS 2019-08-22

NCB Polyaxial Locking Plate System

Applicant Zimmer GmbH

K number K192021

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HRS 2019-08-12

Arsenal Plating System

Applicant Trilliant Surgical

K number K191009

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HRS 2019-08-08

CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System

Applicant In2bones USA, LLC

K number K190385

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HRS 2019-08-06

OrthoPediatrics PediFoot Deformity Corrections System

Applicant OrthoPediatrics Corp.

K number K190992

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HRS 2019-08-01

LOQTEQ VA Calcaneus Plate 3.5

Applicant Aap Implantate AG

K number K182818

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HRS 2019-07-29

CoLink® Mini Plating System

Applicant In2bones USA, LLC

K number K191535

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HRS 2019-07-23

DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional

Applicant Synthes (USA) Products, LLC

K number K190963

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HRS 2019-07-17

ORTHOLOC™ SPS Shoulder Plating System

Applicant Tornier, Inc.

K number K191711

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HRS 2019-06-21

DePuy Synthes Plates and Screws Portfolio

Applicant DePuy Synthes

K number K190750

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HRS 2019-06-19

LOQTEQ VA Foot Plates 2.5

Applicant Aap Implantate AG

K number K182785

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HRS 2019-06-10

Arzzt Distal Radius and Ulna System

Applicant Truemed Group, LLC

K number K182650

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HRS 2019-06-07

RIVAL View Plating Systems and Reduce Fracture Plating Systems

Applicant Orthofix Srl

K number K190388

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HRS 2019-06-06

PROSTEP TBC Implant System

Applicant Wrightmedicaltechnologyinc

K number K183620

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HRS 2019-05-14

ORTHOLOC™ 2 Lapidus with Rotation System

Applicant Wrightmedicaltechnologyinc

K number K190670

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HRS 2019-05-03

MatrixRIB Fixation System

Applicant DePuy Synthes

K number K190409

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HRS 2019-04-19

ATLAS Plating System

Applicant MiRus, LLC

K number K190415

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HRS 2019-04-12

MIS Bunion Plating System

Applicant Crossroads Extremity Systems, LLC

K number K190658

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HRS 2019-04-12

Baby Gorilla/Gorilla Plating System

Applicant Paragon 28, Inc.

K number K190365

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HRS 2019-03-11

EVOS Small Fragment Upper Extremity Plates Line Additions

Applicant Smith & Nephew, Inc.

K number K190253

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HRS 2019-03-05

Stryker SternalPlate System

Applicant Stryker

K number K183172

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HRS 2019-03-04

MLP Special Locking Bone Plate System

Applicant Maxxion Medical, LLC / Baumer SA

K number K181843

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HRS 2019-02-19

MIS Bunion System

Applicant Crossroads Extremity Systems, LLC

K number K181872

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HRS 2019-02-14

AdvantageRib System

Applicant Sig Medical Corporation

K number K183317

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HRS 2019-02-13

EPIC Extremity Fusion Plate System

Applicant Epic Extremity, LLC

K number K182991

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HRS 2019-01-25

Treace Medical Concepts (TMC) Plating System

Applicant Treace Medical Concepts, Inc.

K number K183321

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HRS 2019-01-10

Additive Orthopaedics Patient Specific 3D Locking Lattice Plates

Applicant Additive Orthopaedics

K number K183011

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HRS 2018-12-26

DePuy Synthes Trauma Orthopedic Nail Implants

Applicant DePuy Synthes

K number K182783

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HRS 2018-12-21

TruMatch Graft Cage - Long Bone

Applicant Synthes (Usa), LLC

K number K180821

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HRS 2018-12-10

Distal Radius Plating System

Applicant Miami Device Solutions, LLC

K number K182810

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HRS 2018-11-20

ARIX Sternal System

Applicant Jeil Medical Corporation

K number K181806

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HRS 2018-11-16

Stratum™ Foot Plating System

Applicant Nextremity Solutions, Inc.

K number K182201

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HRS 2018-11-16

AdvantageRib Anterior System

Applicant Sig Medical Corp.

K number K182179

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HRS 2018-11-01

Medline Unite Mini Plates and Screws

Applicant Medline Industries, Inc.

K number K181820

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HRS 2018-11-01

DePuy Synthes Trauma Orthopedic Plates and Screws

Applicant Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.

K number K180310

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HRS 2018-10-30

AOS Calcaneal Plating System

Applicant Advanced Orthopaedic Solutions

K number K182466

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HRS 2018-10-22

ANTHEM Fracture System

Applicant Globus Medical, Inc.

K number K180554

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HRS 2018-10-19

Titanium TomoFix Medial High Tibia Plate Anatomical

Applicant Synthes (USA) Products, LLC

K number K180213

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HRS 2018-10-11

Piccolo Composite® Plate System

Applicant CarboFix Orthopedics , Ltd.

K number K182015

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HRS 2018-10-11

AxSOS 3 Ti

Applicant Stryker GmbH

K number K181091

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HRS 2018-10-10

Geminus Volar Distal Radius Plate System

Applicant Skeletal Dynamics, LLC

K number K182492

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HRS 2018-10-05

ORTHOLOC SPS Shoulder Plating System

Applicant Tornier, Inc.

K number K181587

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HRS 2018-10-04

WishBone Medical Plate and Screw System

Applicant Wishbone Medical, Inc.

K number K180736

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HRS 2018-10-03

ARIX Clavicle System

Applicant Jeil Medical Corporation

K number K180972

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HRS 2018-09-27

CoLink View Plating System

Applicant In2bones USA, LLC

K number K182402

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HRS 2018-09-18

Tandry Locking Plate System

Applicant Microware Precision Co., Ltd.

K number K171904

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HRS 2018-08-24

AOS Small Fragment Plating System Lite

Applicant Advanced Orthopaedic Solutions, Inc. (Aos)

K number K181035

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HRS 2018-08-24

APTUS CMC-I Fusion Plate System

Applicant Medartis AG

K number K181009

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HRS 2018-08-09

EVOS Wrist Fracture Plating System

Applicant Smith & Nephew, Inc.

K number K181533

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HRS 2018-08-05

APTUS® Proximal Humerus System

Applicant Medartis AG

K number K181425

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HRS 2018-08-02

PL8 Wrist Reconstruction Plate

Applicant Citieffe S.R.L.

K number K180150

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HRS 2018-06-15

CoLink™ Afx Plating System

Applicant In2bones USA, LLC

K number K181113

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