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Orthopedic

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

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RecordFirmDate
Arthrex Fracture System (K143139)Arthrex, Inc.2015-01-16
MCS Bone Graft (K142276)Biostructures, LLC2015-01-16
SImmetry Sacroiliac Joint Fusion System (K141549)Zyga Technology, Inc.2015-01-15
CI../..X liner for NOVAE Dual Mobility Acetabular Cup (K142675)Serf2015-01-15
osteoSPAN Morpheus (K142828)Biogennix2015-01-15
OASYS System (K142741)Stryker Corporation2015-01-15
IMPIX ALIF S/A (K141187)Medicrea International SA2015-01-15
Vivorte Trabexus EB (K143547)Vivorte, Inc.2015-01-14
Vivorte Trabexus (K143549)Vivorte, Inc.2015-01-14
Headless Compression Screw System (K143624)Skeletal Dynamics, LLC2015-01-13
Revolution Spinal Fixation System (K142939)Intelligent Implant Systems, LLC2015-01-13
Triathlon Tritanium Cone Augments (K143393)Stryker Orthopaedics2015-01-13
BIOSURE REGENESORB interference Screw (K142948)Smith & Nephew, Inc.2015-01-13
INFIX CANNULATED SCREW SYSTEM (K142057)Infix Medical, LLC2015-01-13
PASS LP SPINAL SYSTEM (K141398)Medicrea International SA2015-01-09
NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM (K141253)New Era Orthopaedics, LLC2015-01-09
SPINOUS PROCESS FUSION (SPF) PLATE (K140046)Spinal Simplicity, LLC2015-01-09
Range/Denali/Mesa Spinal System (K143334)K2m, Inc.2015-01-09
CrossTie Intraosseous Fixation System (K141857)Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem2015-01-08
SIDEKICK EZ FRAME External Fixation System (K143220)Wrightmedicaltechnologyinc2015-01-08
CONSTRUX MINI PEEK; SPACER SYSTEM, TI SPACER SYSTEM, CERVICAL STAND ALONE SYSTEM (K142152)Orthofix, Inc.2015-01-08
MAXIMIS SPINAL FIXATION SYSTEM (K140359)Valorem Surgical2015-01-07
Arsenal Spinal Fixation System (K143149)Alphatec Spine, Inc.2015-01-05
FIREBIRD SPINAL FIXATION SYSTEM (K141186)Orthofix, Inc.2015-01-02
LITe Plate System (K142699)Stryker Corporation2014-12-31
3.Omm Biomet Cannulated Screw System (K143188)Biomet Manufacturing Corp2014-12-30
ACROSSPINE PEDICLE SCREW SYSTEM (K141695)Arthro-Dif2014-12-30
G7 Finned Acetabular Shell (K142746)Biomet Manufactuting Corp.2014-12-29
VECTRIX EXTERNAL FIXATOR (K140649)3D Medical Concepts, LLC2014-12-29
Biomet Tibial trays (K142933)Biomet, Inc.2014-12-23
Wrist Hemiarthroplasty System (K141920)Arthrosurface, Inc.2014-12-23
nvc (K142328)Nvision Biomedical Technologies, LLC2014-12-23
ALIANS ULNA LOCKING PLATING SYSTEM (K142502)Newclip Technics2014-12-23
Klassic HD Hip System (K143407)Total Joint Othopedics, Inc.2014-12-23
Caspian OCT/MESA Mini/DENALI Mini Spinal System (K142558)K2m2014-12-22
Zimmer Persona Personalized Knee System (K142787)Zimmer, Inc.2014-12-22
AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mm (K142528)Agent Medical, LLC2014-12-22
AxSOS 3 Ti Locking Plate System (K143138)Stryker Trauma AG2014-12-22
ANTHEM PS Total Knee System (K142807)Smith & Nephew, Inc.2014-12-22
Reform Pedicle Screw System (K143248)Precision Spine, Inc.2014-12-19
AIS Odontoid Fracture Fixation System (K142707)Aesculap Implant System, Inc.2014-12-19
Zavation Z-Link Lumbar (K142271)Zavation, LLC2014-12-19
POROSTEON PHUSION METAL CERVICAL CAGE (K142041)Porosteon, Inc.2014-12-19
ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS STAPLE (K142111)Novatsep2014-12-19
HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System (K142942)Arthrosurface, Inc.2014-12-19
Interspinous Plate System (K142378)Precision Spine, Inc.2014-12-18
Bio2 CLM BG Bioactive Scaffold (K142463)Bio2 Technologies, Inc.2014-12-18
FASTFORWARD (K141420)MedShape, Inc.2014-12-18
MAS PLIF Fixation system (K142737)Nu Vasive, Incorporated2014-12-18
Threshold Pedicular Fixation System (K143403)Spineology, Inc.2014-12-18
ARTHREX SUTURETAK SUTURE ANCHORS (K140855)Arthrex, Inc.2014-12-18
SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene (K142488)Seaspine, Inc.2014-12-18
VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws (K143050)Smith & Nephew, Inc.2014-12-18
Echo Bi-Metric Microplasty Hip System (K143009)Biomet, Inc.2014-12-18
Mini and Micro Fragments Reconstruction System-NEOFIX (K142419)Neoortho Productos Orthopedicos S/A2014-12-16
Stabilynx PEEK Suture Anchor (K142643)D3 Dc, LLC /Stabilynx, Inc.2014-12-15
NEXTGEN ALTIUS OCT SYSTEM (K140734)Ebi, LLC2014-12-15
ProxiFuse Hammer Toe Device (K142490)Cartiva, Inc.2014-12-15
iTotal Posterior Stabilized (PS) Knee Replacement System (K142404)Conformis, Inc.2014-12-11
IBIS PEDICLE SCREW SYSTEM (K142146)Ortho Development Corp.2014-12-11
G7 OSSEOTI ACETUBLAR SHELLS (K140669)Biomet, Inc.2014-12-11
Crystal ®; Mosaic ®; Vertu ® (K133218)Spinal Elements, Inc.2014-12-10
Orthofix True Lok Hexapod System VI.3 (K143125)Orthofix Srl2014-12-10
ORTHOFIX GALAXY WRIST (K141760)Orthofix Srl2014-12-08
HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBAR (K141557)Gallini Medical Devices, Srl2014-12-08
Valeo C Spacer System, Valeo II C IBF Device (K142264)Amedica Corp.2014-12-08
Neo Total Knee System (K142388)New Era Orthopedics, LLC2014-12-05
ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT (K142052)Orthofix Srl2014-12-05
TOTAL COMPRESSION PLATING SYSTEM (K143025)Wrightmedicaltechnologyinc2014-12-05
ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEM (K141632)Medtronic Sofamor Danek USA, Inc.2014-12-04
GMK EXTENSION (K142069)Medacta International2014-12-02
PGS 5.5 MM CANNULATED PEDICLE SCREW (K141282)Pinnacle Spine Group2014-12-02
CD HORIZON Spinal System (K143141)Medtronic Sofamor Danek USA, Inc.2014-12-01
JULIET LL (K141135)Spineart2014-12-01
CD HORIZON Spinal System (K142591)Medtronic Sofamor Danek USA, Inc.2014-12-01
Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws and Washers (K143066)Zimmer, Inc.2014-11-28
nva, nvp, nvt (K142594)Nvision Biomedical Technologies, LLC2014-11-28
G3 Active Plate Large Fragment System (K142938)Genesis Fracture Care, Inc.2014-11-26
Univers Rivers Shoulder Prosthesis System (K142863)Arthrex, Inc.2014-11-25
ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE (K141333)Spinefrontier, Inc.2014-11-25
CoRoent Small Interlock System (K142299)Nu Vasive, Incorporated2014-11-25
IN:C2 SPINAL FIXATION SYSTME (K141537)Spine Smith Holdings, LLC2014-11-25
OPTICAGE EXPANDABLE INTERBODY FUSION DEVICE (K140716)Interventional Spine, Inc.2014-11-24
KangLi pedical screw spinal system (K142290)Suzhou Kangli Orthopaedics Instrument Co., Ltd.2014-11-24
Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System (K142403)Zimmer GmbH2014-11-24
GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS) (K142072)Custom Orthopaedic Solutions, Inc.2014-11-24
VEGA Knee System (K143106)Aesculap Implant Systems, LLC2014-11-21
BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD (K141377)Merete Medical GmbH2014-11-21
LUNA INTERBODY SYSTEM (K142023)Benvenue Medical, Inc.2014-11-20
Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software (K142520)Smith & Nephew, Inc.2014-11-20
PhaLinx Hammertoe System (K142585)Wrightmedicaltechnologyinc2014-11-20
COROENT SYSTEM (K141896)Nu Vasive, Incorporated2014-11-20
TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS (K141263)Biomet Manufacturing Corp2014-11-19
AVS AS PEEK Spacer (K142251)Stryker Corporation2014-11-19
Arthrex iBalance Patella Implant, Dome (K143047)Arthrex, Inc.2014-11-19
EXPEDIUM VERSE SPINE SYSTEM (K142185)Depuy Spine, Inc.2014-11-19
Reline System (K142499)Nu Vasive, Incorporated2014-11-19
Vertical Expandable Prosthetic Titanium Rib (K142587)Depuy Synthes Spine, Inc.2014-11-18
TRANSOM ANTERIOR CERVICAL PLATE (K142060)Neurostructures, Inc.2014-11-18
J-SCREW COMPRESSION SCREW (K130019)Competitive Engineering, Inc.2014-11-18
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