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Orthopedic

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

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RecordFirmDate
Blue Mountain Cervical Plate System (K150036)Spineway2015-05-07
Modified Bencox Hip System (K150007)Corentec Co., Ltd.2015-05-04
Pyrenees Cervical Plate System (K142212)K2m, Inc.2015-05-01
Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System (K150818)Zimmer, Inc.2015-05-01
Rush Medullary Pins (K150626)Zimmer, Inc.2015-05-01
G7 Dual Mobility System (K150522)Biomet, Inc.2015-05-01
INCITE ANCHORED CERVICAL INTERBODY DEVICE (K150913)Incite Innovation2015-04-30
G3 Active Plate Large Fragment System (K150649)Genesis Fracture Care, Inc.2015-04-30
aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, Titanium (K150974)Aap Implantate AG2015-04-29
Arthrex Plates, Screws, and Staples (K150456)Arthrex, Inc.2015-04-29
Republic Spine Dark Star Spinal System (K150283)Republic Spine, LLC2015-04-29
SMV Scientific 4.5 mm Bone Screws (K150188)Summit Medventures2015-04-29
DARCO Locking Bone Plate System (K150520)Wrightmedicaltechnologyinc2015-04-29
Cardinal Health External Fixation System (K150579)Cardinalhealth2015-04-29
NuVasive(R) CCX-L Interbody System (K143595)Nu Vasive, Incorporated2015-04-29
Reliance Posterior Cervical-Thoracic System (K142867)Reliance Medical Systems, LLC2015-04-29
PHALINX Hammertoe System (K150252)Wrightmedicaltechnologyinc2015-04-29
Zavation Posterior LEIF (K142392)Zavation, LLC2015-04-29
KYPHON (R) HV-R(R) Bone Cement (K150460)Medtronic Sofamor Danck USA, Inc.2015-04-28
Streamline OCT Occipito-Cervico-Thoracic System (K150254)Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2015-04-28
SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System (K150017)Spinefrontier, Inc.2015-04-24
SOLSTICE OCT System (K142253)Life Spine, Inc.2015-04-23
Aequalis PerFORM+ Shoulder System (K150583)Tornier, Inc.2015-04-23
Zimmer Nexel Total Elbow Ulnar Cement Diverter (K150501)Zimmer, Inc.2015-04-23
INTERBODY CAGE (K140348)Eisertech, LLC2015-04-23
PRECICE Intramedullary Limb Lengthening System (K150656)Ellipse Technologies, Incorporated2015-04-23
NuVasive Reline System (K143684)Nu Vasive, Incorporated2015-04-23
VENUS Spinal Fixation System (K143363)L&K BIOMED Co., Ltd.2015-04-22
POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA (K143739)Smith & Nephew, Inc.2015-04-20
PROFEMUR Preserve Size 1-3 Hip Stems (K150133)Microport Orthopedics, Inc.2015-04-20
OSTEOTEC SILICONE FINGER IMPLANT (K140453)Osteotec, Ltd.2015-04-17
ProCinch Adjustable Loop Device (K150416)Stryker Endoscopy2015-04-17
SI-BONE iFuse Implant System (K150714)SI-BONE, Inc.2015-04-17
IMPLANET Spine System (ISS) (K143731)Implanet, S.A.2015-04-14
FortiBridge Anterior Cervical Plate System (K143706)Nanovis Spine, LLC2015-04-10
PROFEMUR Preserve Classic Stem (K150302)Microport Orthopedics, Inc.2015-04-10
GPS Spacers (K142456)G Surgical, LLC2015-04-10
Arthrex Blunt Tip Screws with Fiber Tape (K143702)Arthrex, Inc.2015-04-09
PLIF STS, TLIF STS, OLIF STS (Spinal Truss System) (K143258)4Web, Inc.2015-04-09
APTUS Foot System (K142581)Medartis AG2015-04-09
Equinoxe Mega Prosthesis (K143659)Exactech, Inc.2015-04-09
Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml (K150607)Osseon, LLC2015-04-09
Polyscrew Pedicle Screw System (K150647)New Era Orthopedics, LLC2015-04-08
CD HORIZON Spinal System, IPC POWEREASE System (K143019)Medtronic Sofamor Danek USA, Inc.2015-04-08
BLUEPRINT Patient Specific Instrumentation (K143374)Tornier S.A.S.2015-04-08
CONVENTUS PHS SYSTEM (K141737)Conventus Orthopaedics, Inc.2015-04-08
SOLSTICE OCT System (K150229)Life Spine, Inc.2015-04-07
SOLSTICE OCT System (K143249)Life Spine, Inc.2015-04-07
Airlock osteosynthesis plate system (K143523)Novastep2015-04-06
Acumed Ankle Plating System (K143385)Acumed, LLC2015-04-06
Corin TaperFit Hip Stem (K142761)Corin USA2015-04-03
InFill Interbody Fusion Devices (K150206)Pinnacle Spine Group, LLC2015-04-03
Santis Pedicle Screw System (K150507)Lanterna Medical Technologies2015-04-03
Aptis Medical Distal Radio Ulnar Joint Implant (K142569)Aptis Medical, LLC2015-04-03
LnK Cervical Interbody Fusion Cage System (K143360)L&K BIOMED Co., Ltd.2015-04-03
Arthrex Distal Radius System (K143749)Arthrex, Inc.2015-04-03
Reliance Interspinous Plate System (K142217)Reliance Medical Systems, LLC2015-04-02
PHYSICA KR KNEE SYSTEM (K141934)Lima Corporate S.P.A.2015-04-02
Range/Denali/Mesa Spinal System (K150325)K2m, Inc.2015-03-31
Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Bone Screw (K143165)Zimmer, Inc.2015-03-31
Coalition AGX Plate and Coalition AGX Spacer (K142218)Globus Medical, Inc.2015-03-31
Eminent Foot Plate System (K143365)Eminent Spine2015-03-30
Biomet Proximal Humerus Plating System (K143697)Biomet Manufacturing2015-03-30
DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM (K141527)Synthes USA2015-03-30
Echo Bi-Metric Microplasty Line Extension (K150503)Biomet, Inc.2015-03-25
VEGA Knee System, Columbus Total Knee System (K143443)Aesculap Implants Systems, LLC2015-03-25
Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock All-Suture Anchor, 1.4mm with (1) size 2-0 UHMWPE suture with needles (K143473)Cayenne Medical, Inc.2015-03-25
PASS LP Spinal System (K142798)Medicrea International SA2015-03-25
INVISION TOTAL ANKLE REVISION SYSTEM (K142117)Wrightmedicaltechnologyinc2015-03-25
FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE (K143533)Prosidyan, Inc.2015-03-25
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM (K141278)Ellipse Technologies, Inc.2015-03-24
SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA (K143096)Smith & Nephew, Inc.2015-03-24
Progressive Orthopedic Total Knee System (K142649)The Progressive Orthopaedic Company, LLC2015-03-24
Tarsa-Link Wedge Fixation System (K150368)Life Spine2015-03-24
Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws) (K150099)Synthes (USA) Products, LLC2015-03-23
Flow-Screw (K142776)Flow-Fx, LLC2015-03-23
Integra Laminoplasty System (K150469)Seaspine, Inc.2015-03-23
inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation System (K143626)Zimmer Spine, Inc.2015-03-20
F1-Modular Pedicle Screw System (K142531)Degen Medical2015-03-20
ARROW Reverse Shoulder long keel and short keel glenoid base (K142778)Fournitures Hospitalieres Industrie2015-03-20
Xenco Medical Lumbar Interbody System (K143158)Xenco Medical, LLC2015-03-20
LnK Anterior Cervical Plate System (K143279)L&K BIOMED Co., Ltd.2015-03-20
PROXIMAL HUMERUS PLATING SYSTEM (K141493)Miami Device Solutions2015-03-20
RESTORIS POROUS PARTIAL KNEE SYSTEM (K150410)Mako Surgical Corporation2015-03-20
LITe Plate System (K150449)Stryker Corp.2015-03-20
Treace Medical Concepts(TMC) Plating System (K143717)Treace Medical Concepts, Inc.2015-03-19
Evolve UniPolar Head (K143184)Signature Orthopaedics Pty, Ltd.2015-03-17
Nautilus Spinal System (K150390)Life Spine, Inc.2015-03-16
NuVasive CoRoent System (K141665)Nuvasive, Inc.2015-03-13
Biomet Spine Fusion System (K142634)Biomet Spine, LLC2015-03-12
RESTORIS Multicompartmental Knee System (K150307)Mako Surgical Corp.2015-03-10
InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm) (K150322)Pan Medical , Ltd.2015-03-06
Leva(TM) Spacer System (K150285)Spine Wave, Inc.2015-03-05
NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System (K143134)Cossington, Ltd.2015-03-05
AccuLIF TL and PL Cage (K143616)Stryker Corporation2015-03-05
Affix IIS Spinous Process Plate System (K143388)Nu Vasive, Incorporated2015-03-05
NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System Genta (K143100)Cossington, Ltd.2015-03-05
INFINITY (TM) TOTAL ANKLE SYSTEM; INBONE TOTAL ANKLE SYSTEM (K141740)Wrightmedicaltechnologyinc2015-03-05
SALVATION External Fixation System (K150004)Wrightmedicaltechnologyinc2015-03-04
Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS (K143331)Zimmer, Inc.2015-03-04
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