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Orthopedic

17,044 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft (K200064)SurGenTec, LLC2020-08-14
Univers Revers Modular Glenoid System, Half Augment Baseplate (K200895)Arthrex, Inc.2020-08-13
Exeter V40 Femoral Stem, Exeter X3 RimFit Cup (K193429)Howmedica Osteonics Corp.2020-08-13
IlluminOss Photodynamic Bone Stabilization System (K201961)Illuminoss Medical, Inc.2020-08-13
SpaceFlex Knee - 80mm Size (K201960)G21, S.R.L.2020-08-13
UNIKO PointCloud™ Knee Instruments (K193312)Unik Orthopedics, Inc.2020-08-12
Osteo-site Vertebral Balloon (K200763)Izi Medical2020-08-12
Mega Plus MIS Spine System (K200981)Bk Meditech, Co., Ltd.2020-08-11
Lateralized Glenosphere (K193175)Medacta Inernational SA2020-08-11
Precice® Bone Transport System (K201567)Nuvasive Specialized Orthopedics, Inc.2020-08-10
Monterey AL Interbody System (K201585)Stryker Corporation2020-08-10
GS Medical AnyPlus PEEK Cage System (K200592)GS Medical Co., Ltd.2020-08-10
CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System (K201926)CarboFix Orthopedics , Ltd.2020-08-07
6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor (K201883)Medos International SARL2020-08-07
Medina Anterior Cervical Plate System (K201521)Alliance Partners, LLC2020-08-06
NADIA SI Fusion System (K190580)Ilion Medical, Inc.2020-08-05
Smart Toe II, X Fuse (K201715)Stryker GmbH2020-08-05
LATITUDE EV™ Total Elbow Arthroplasty (K193247)Tornier, Inc.2020-08-05
Spartan Hip Stem (K192883)Signature Orthopaedics Pty, Ltd.2020-08-05
Aurora® Anterior Lumbar Plate Sytstem (K201079)Prism Surgical Design Pty , Ltd.2020-08-05
Mariner Cap System (K201240)SeaSpine Orthopedics Corporation2020-08-05
CureOs TCP (K191670)Linacol Muh Dan Kim Cev Tek Med Ith Ihr San VE Tic2020-08-04
Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar Spacer (K201500)Life Spine, Inc.2020-08-04
Corin Optimized Positioning System (OPS) Femoral (K193545)Corin USA2020-08-04
CoFix System (K201704)Paradigm Spine GmbH2020-08-04
Vector Hammertoe Correction System (K201850)Nvision Biomedical Technologies, Inc.2020-08-04
CORBEL Spacers (K201087)Globus Medical, Inc.2020-07-31
Cemented Origin Hip Stem (K201951)Signature Orthopaedics Pty, Ltd.2020-07-31
MAGEC® System (K201543)Nuvasive Specialized Orthopedics, Inc.2020-07-30
Sterispine™ PS (K201648)Safe Orthopaedics2020-07-30
OSSIOfiber™ Compression Screws (K193660)OSSIO , Ltd.2020-07-30
EXULT Femoral component trial - Left, EXULT Femoral component trial - Right (K201851)Corentec Co., Ltd.2020-07-30
Arthrex Mini Hip PushLock (K201786)Arthrex, Inc.2020-07-30
Pitkar External Fixation System - Rail Mechanism (K200518)S.H.Pitkar Orthotools Pvt. , Ltd.2020-07-29
Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling (K200959)Biomet UK, Ltd.2020-07-29
AccelFix Lumbar Plate System (K192481)L&K BIOMED Co., Ltd.2020-07-28
Arthrex Compression Screws (K201132)Arthrex, Inc.2020-07-27
Stratum™ Reduced Size Foot Plating System (K200785)Nextremity Solutions, Inc.2020-07-27
DePuy Synthes 2.7mm VA LCP Clavicle Plate System (K201321)DePuy Synthes2020-07-24
Transept Cervical Plate System (K200927)Neurostructures, Inc.2020-07-24
Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors (K201083)Parcus Medical, LLC2020-07-23
EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm) (K201527)Smith & Nephew, Inc.2020-07-22
True Tulip System, True M.I.S. System (K201780)Innovative Surgical Designs, Inc.2020-07-22
DAC Dynamic Active Compression Plate (K200513)Pioneer Surgical Technology, Inc., Dba Rti Surgical2020-07-22
Pedicle Screw System (K201751)Black Box Medical, LLC2020-07-22
Gamma3 System (K200869)Stryker Trauma GmbH2020-07-22
Smith+Nephew Arthroscopes (K201349)Smith & Nephew2020-07-20
LINK TrabecuLink Femoral Cones (K201364)Waldemar Link GmbH & Co. KG2020-07-17
Phantom® Hindfoot TTC/TC Nail System (K201227)Paragon 28, Inc.2020-07-17
ZCA All-Poly Acetabular Cups (K191449)Zimmer, Inc.2020-07-16
TiN Coated Humeral Head (K191698)Fx Shoulder USA, Inc.2020-07-16
KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System (K201660)Kyocera Medical Technologies, Inc.2020-07-16
Barricaid Instrument Tray (K201676)Intrinsic Therapeutics, Inc.2020-07-16
REDUCT® Headless Compression Screw System (K201662)Skeletal Dynamics, Inc.2020-07-16
CoLink Plating System (K201149)In2bones USA, LLC2020-07-15
TxTiHA IBF System, AxTiHA Stand-Alone ALIF System (K201614)Innovasis, Inc.2020-07-15
Humelock TiN Coated Glenosphere (K191146)Fx Shoulder USA, Inc.2020-07-15
EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage (K201605)Eit Emerging Implant Technologies GmbH2020-07-15
Triathlon Total KneeSystem (K201343)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2020-07-10
Paragon 28 APEX 3D Total Ankle Replacement System (K192994)Paragon 28, Inc.2020-07-10
Zimmer, Inc. Hip Joint Prostheses MR Labeling I (K200823)Zimmer, Inc.2020-07-09
Delta Multihole TT Pro Acetabular System (K200656)Lima Corporate S.P.A.2020-07-08
Arthrex DynaNite Compression Plate (K193345)Arthrex, Inc.2020-07-08
Intraosseous Fixation System (K201556)Extremity Medical, LLC2020-07-08
Arthrex Eclipse Shoulder Prosthesis System (K201542)Arthrex, Inc.2020-07-08
Arthrex MaxForce MTP Compression Plates and Screws (K201235)Arthrex, Inc.2020-07-06
Luna XD Ti Interbody Fusion System (K193172)Benvenue Medical, Inc.2020-07-02
T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (GTN),T2 Ankle Arthrodesis Nail,T2 Arthrodesis Nail System (K200880)Stryker GmbH2020-07-01
Kinos Axiom Total Ankle System (K192778)Kinos Medical2020-06-30
Altapore MIS (K201464)Baxter Healthcare Corporation2020-06-30
Cadence Total Ankle System (K201507)Integra LifeSciences Corporation2020-06-29
Arthrex DynaNite K-Wire (K200068)Arthrex, Inc.2020-06-29
RetroFix (K200226)Retrofix Screws, LLC2020-06-26
DuoHex CH Cannulated Hammertoe System (K200840)Nextremity Solutions, Inc.2020-06-26
Rotium Bioresorbable Wick (K201414)Nanofiber Solutions, LLC2020-06-25
IlluminOss Bone Stabilization System (K200295)Illuminoss Medical, Inc.2020-06-25
Lever Action Plate System (K200834)Mcginley Orthpaedic Innovations, LLC2020-06-25
The Simple Locking Intramedullary (Slim) System (K192710)Pega Medical, Inc.2020-06-24
InFrame™ Cannulated Fixation System (K201430)Exsomed Corp.2020-06-20
Cemented TSI Hip Stem (K192024)Signature Orthopaedics Pty, Ltd.2020-06-19
SpineFrontier Lumbar Interbody Fusion Device System (K193106)Spinefrontier, Inc.2020-06-19
DePuy ATTUNE™ Total Knee System (K201347)DePuy Orthopaedics, Inc.2020-06-18
SIGNAFUSE Bioactive Bone Graft (K193513)Bioventus2020-06-18
Medussa-PL Cage (K200283)Medyssey USA, Inc.2020-06-18
Medline UNITE Jones Fracture Screw System (K201319)Medline Industires, Inc.2020-06-17
Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System (K201029)Spinal Elements, Inc.2020-06-17
iTotal® Identity Posterior Stabilized Knee Replacement System (K201023)Conformis, Inc.2020-06-16
Spinal Fixation System (K190408)Shangdong Kangsheng Medical Devices Co., Ltd.2020-06-16
TRUMATCH Personalized Solutions (K193540)DePuy Orthopaedics, Inc.2020-06-16
F3D Cervical Stand-Alone Interbody Fusion System (K200087)Corelink, LLC2020-06-15
Centurion POCT System (K201481)Orthofix, Inc.2020-06-15
RIGEL 3DR Anterior Cervical Interbody Fusion System (K200685)MiRus, LLC2020-06-11
Auxein Nailing System (K192003)Auxein Medical Private Limited2020-06-10
SeaSpine Meridian System, SeaSpine Regatta Lateral System (K200879)SeaSpine Orthopedics Corporation2020-06-10
Osteo3 ZP Putty (K193075)Sirakoss , Ltd.2020-06-09
The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System (K193067)Wrightmedicaltechnologyinc2020-06-08
AxSOS 3 AF System and AxSOS 3 Ti System (K200398)Stryker GmbH2020-06-05
Signature ONE System (K200615)Orthosoft Inc (D/B/A Zimmer Cas)2020-06-05
CarboClear® Cervical Plate System (K200883)CarboFix Orthopedics , Ltd.2020-06-04
HEALIX ADVANCE Anchor with DYNATAPE Suture (K200949)Medos International SARL2020-06-04
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