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Orthopedic

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

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RecordFirmDate
WishBone Medical Plate and Screw System (K203467)Wishbone Medical, Inc.2020-12-23
F3D Corpectomy System (K202637)Corelink, LLC2020-12-23
AltiVate® Anatomic Pegged Glenoid with Markers (K203026)Encore Medical L.P.2020-12-23
Omnia Medical TiBrid-SA (K203207)Omnia Medical, LLC2020-12-23
External Remote Controller ERC 4P (K202348)Nuvasive Specialized Orthopedics, Inc.2020-12-22
Nano FortiFix® System (K203452)Nanovis, LLC2020-12-22
ChoiceSpine Tiger Shark Cervical Spacer System (K201643)Choice Spine, LLC2020-12-22
Lucent XP, Lucent XP Curved (K202298)Spinal Elements, Inc.2020-12-22
Australis Anterior Lumbar Cage System (K202820)Prism Surgical Designs Pty, Ltd.2020-12-22
Impulse Interbody Fusion System (K201287)Degen Medical2020-12-22
iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement (K203447)Conformis, Inc.2020-12-22
Resascope RS-01/B (K201113)Advanced Medical Systems Group Srl2020-12-21
Trigon HA Stand-Alone Wedge Fixation System (K203445)Nvision Biomedical Technologies, Inc.2020-12-21
Invictus™ OCT Spinal Fixation System (K203125)Alphatec Spine, Inc.2020-12-18
IdentiTi Cervical Standalone Interbody System (K202812)Alphatec Spine, Inc.2020-12-18
ARx Illiac Spinal Screw System (K203163)Life Spine, Inc.2020-12-17
PERLA TL Posterior Osteosynthesis System (K203222)Spineart2020-12-17
SMR 140° Reverse Humeral Body (K201905)Lima Corporate S.P.A.2020-12-17
BEAR (Bridge-Enhanced ACL Repair) Implant (DEN200035)Miach Orthopaedics, Inc.2020-12-16
DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System (K203414)DePuy Synthes2020-12-16
Arthrex DynaNite Nitinol Staples (K203180)Arthrex, Inc.2020-12-16
CREED™ Cannulated Screws (K200291)Glw Medical, Inc.2020-12-16
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) (K202289)Stryker GmbH2020-12-16
Lucero Medical Cervical Cage System (K200549)Lucero Medical, LLC2020-12-16
WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System (K201755)SeaSpine Orthopedics Corporation2020-12-15
NEXXT MATRIXX Stand Alone ALIF System (K202230)Nexxt Spine, LLC2020-12-15
Fixone All Suture Anchor (K192709)Aju Pharm Co., Ltd.2020-12-15
Javelin Tailor's Bunion Fixation System (K202657)Nvision Biomedical Technologies, Inc.2020-12-14
Physica system (K201084)Lima Corporate S.P.A.2020-12-14
ELEOS Limb Salvage System featuring BIOGRIP (K203090)Onkos Surgical2020-12-11
GMK Total Knee System - TiNbN Coating (K202684)Medacta International S.A.2020-12-11
PROFEMUR® GLADIATOR® Cemented Classic Stem (K201519)Microport Orthopedics, Inc.2020-12-10
Posterior Fusion Plate, HA Posterior Fusion Plate (K200066)Spinal Simplicity, LLC2020-12-10
Zimmer Segmental System (K192798)Zimmer, Inc.2020-12-10
Accu-Joint Hemi Implant (K200951)Accufix Surgical, Inc.2020-12-08
Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation (K201253)Smith & Nephew2020-12-08
Taperloc® Complete Hip Stems (K200196)Biomet Orthopedics2020-12-08
LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal System (K200789)L&K BIOMED Co., Ltd.2020-12-04
NuVasive ACP System (K203253)Nu Vasive, Incorporated2020-12-03
LineSider™ Spinal System (K203367)Integrity Implants, Inc.2020-12-03
aprevo Intervertebral Body Fusion Device (K202034)Carlsmed, Inc.2020-12-03
Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 (K201072)Ensemble Orthopedics, LLC2020-12-02
SMS Cementless Stem (K203041)Medacta International S.A.2020-12-02
Stryker Arthroscope (K202659)Stryker2020-12-01
Arthrex FiberTak Suture Anchor (K203268)Arthrex, Inc.2020-11-27
GLOBAL UNITE™ Platform Shoulder System (K202098)Depuy Ireland UC2020-11-25
TopLock Anchor System (K193377)Fusion Orthopedics, LLC2020-11-25
Sterile bone screw (PEEK ACL screw) (K202883)Osteonic Co., Ltd.2020-11-25
CarboClear X Pedicle Screw System (K203317)CarboFix Orthopedics , Ltd.2020-11-25
SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene; SeaSpine Vu e•POD System; and SeaSpine Reef TH System, SeaSpine Vu a•POD Prime NanoMetalene IBD; and SeaSpine Shoreline ACS, SeaSpine Cambria System; SeaSpine Regatta Lateral System; and SeaSpine Meridian System, Shoreline Cervical Interbody RT System; and SeaSpine Beachside System (K201193)SeaSpine Orthopedics Corporation2020-11-25
ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology (K202194)Depuy Ireland UC2020-11-25
Anterior Cervical Plate System (K202972)Nutech Spine and Biologics2020-11-24
PolyLock Plating System (K202959)Fusion Orthopedics, LLC2020-11-24
PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G (K202475)Heraeus Medical GmbH2020-11-23
Invictus™ Spinal Fixation System (K203056)Alphatec Spine, Inc.2020-11-23
Ortho Solutions Plating System (K202764)Ortho Solutions UK , Ltd.2020-11-20
Arthrex Eclipse Titanium Humeral Head (K203100)Arthrex, Inc.2020-11-20
SMR TT Augmented Glenoid System (K200171)Lima Corporate S.P.A.2020-11-19
DePuy Corail AMT Hip Prosthesis (K203167)DePuy Orthopaedics, Inc.2020-11-19
Freedom(R) - TiNbN Coated Knee (K200912)Maxx Orthopedics, Inc.2020-11-18
FIREBIRD SI Fusion System (K203138)Orthofix, Inc.2020-11-18
Arthrex FastThread Interference Screw (K202535)Arthrex, Inc.2020-11-18
Knotless TensionTight Button Implant System (K202444)Arthrex, Inc.2020-11-17
Activ Fuse (K202307)Newclip Technics2020-11-17
VeriFixx™ Small Bone Implant (K202777)Armis Biopharma, Inc.2020-11-17
Circular Fixation with Balanced Cable Transport (K202762)Smith & Nephew, Inc.2020-11-16
M.U.S.T. MINI Posterior Cervical Screws System (K203149)Medacta International S.A.2020-11-16
EVOS Large Fragment Plating System (K201918)Smith & Nephew, Inc.2020-11-16
Stryker Omega PEEK Knotless Anchor System (K202355)Stryker2020-11-13
Monster Screw System (K203011)Paragon 28, Inc.2020-11-13
APEX 3D Total Ankle Replacement System (K202373)Paragon 28, Inc.2020-11-13
VersaLoop Anchor System (K202178)T.A.G. Medical Products Corporation, Ltd.2020-11-13
AGILON® XO Shoulder Replacement System (K191433)Implantcast GmbH2020-11-12
Calvary Spine Pedicle Screw System (K201568)Calvary Spine, LLC2020-11-12
WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws (K193214)Biomet, Inc.2020-11-10
Multi-Drive Interference Screw System (K200428)Nvision Biomedical Technologies, Inc.2020-11-10
Vantage PSI System (K193432)3D Systems2020-11-09
APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System (K202589)Medartis AG2020-11-06
Mecta-C Stand Alone Extension (K203076)Medacta International S.A.2020-11-06
ATEC Lateral Interbody System (K202587)Alphatec Spine, Inc.2020-11-06
KASILOF Cervical Plate System (K203154)Kahtnu Surgical, Inc.2020-11-05
Salvo® Spine System (K202476)Spine Wave, Inc.2020-11-05
Z-Span Plate System (K202624)Zavation Medical Products, LLC2020-11-04
Arthrex TightRope II (K202581)Arthrex, Inc.2020-11-04
FlareHawk Interbody Fusion System (K202198)Integrity Implants, Inc.2020-11-03
Atlas Spine Rebar (Ti) Spacer System (K202302)Atlas Spine, Inc.2020-10-30
UNiD IB3D ALIF (K200316)Medicrea International SA2020-10-30
ANTHEM Fracture System (K202496)Globus Medical, Inc.2020-10-29
Libertas E-XLPE Modular Liner (K192989)Maxx Orthopedics, Inc.2020-10-29
ARIX Ankle Distal Tibia System (K202912)Jeil Medical Corporation2020-10-29
NuVasive Modulus XLIF Interbody System (K201692)Nu Vasive, Incorporated2020-10-29
EXPERT - Joint Fixation System (K200332)GM Dos Reis Industria e Comercio Ltda.2020-10-29
CONSTRUX Mini PEEK Spacer System (K202949)Orthofix, Inc.2020-10-29
Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip (K202259)Parcus Medical, LLC2020-10-28
EVOS Cabling System (K201497)Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2020-10-28
LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System (K200790)L&K BIOMED Co., Ltd.2020-10-28
Comprehensive Shoulder System (K193038)Biomet Manufacturing Corp2020-10-28
Syntec Femoral Nail Extended System (K202935)Syntec Scientific Corporation2020-10-28
Triathlon PKR System (K203099)Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2020-10-27
IlluminOss Bone Stabilization System (K202887)Illuminoss Medical, Inc.2020-10-27
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