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Orthopedic

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

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RecordFirmDate
ARIX Hand System (K161746)Jeil Medical Corporation2016-09-21
QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments (K161591)Globus Medical, Inc.2016-09-21
Spinal fixation system (K161151)Canwell Medical Co., Ltd.2016-09-21
Cascadia Interbody System (K162264)K2m, Inc.2016-09-21
Syntorr K-wire and Pin System (K161489)Syntorr, Inc.2016-09-16
mi-eye 2, mi-eye 2 monitor (K162475)Trice Medical2016-09-16
PROW FUSION-L (K153665)Nlt Spine, Ltd.2016-09-15
SeaSpine Shoreline ACS - Anterior Cervical Standalone System (K161081)SeaSpine Orthopedics Corporation2016-09-14
JULIET® LL Lateral Lumbar Cage (K161888)Spineart2016-09-12
Tritium® Sternal Cable Plate System (K161876)Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.2016-09-09
StageOne Select Cement Spacer Molds for Temporary Hip Replacement (K161166)Biomet, Inc.2016-09-08
RTS Flexible 1 MPJ Implant w/Grommets (K153609)In2bones USA, LLC2016-09-08
PILLAR SA PTC (K161129)Orthofix, Inc.2016-09-08
SeaSpine® NewPort™ Spinal System (K161535)SeaSpine Orthopedics Corporation2016-09-08
Battalion Universal Spacer System (K160958)Alphatec Spine2016-09-08
coflex-IF (K153302)Paradigm Spine, LLC2016-09-08
Additive Orthopaedics Bone Wedge System (K153207)Additive Orthopaedics, LLC2016-09-07
GENflex2 Total Knee System (K162222)Stelkast, Inc.2016-09-07
Xenco Medical Posterior Cervical System (K161478)Xenco Medical, LLC2016-09-06
Nanovis Intervertebral Body Fusion System and Forticore(R) (K161485)Nanovis, LLC2016-09-06
Active-X Total Knee System (K160159)Signature Orthopaedics Pty, Ltd.2016-09-06
Pro-Link® Stand-Alone Cervical Spacer System (K160066)Life Spine, Inc.2016-09-02
Tangis Anterior Cervical Plate (K161524)Nvision Biomedical Technologies, LLC2016-09-02
MAGEC® Spinal Bracing and Distraction System (K161751)Nuvasive Specialized Orthopedics, Inc.2016-09-02
LigaPASS (K160698)Medicrea International SA2016-09-02
Exactech® Novation® Element Press-fit Femoral Stem (K153649)Exactech, Inc.2016-08-31
ANAX™ 5.5 Spinal System (K162189)U&I Corporation2016-08-30
INDEPENDENCE MIS Spacers (K160597)Globus Medical, Inc.2016-08-29
Arthrex VaultLock Glenoid (K161108)Arthrex, Inc.2016-08-29
Integra TITAN Reverse Shoulder System (K161189)Integra LifeSciences Corporation2016-08-25
G Surgical Marksman MIS System (K161516)G Surgical, LLC2016-08-25
NuVasive Lumbar Interbody Implants (K161230)Nu Vasive, Incorporated2016-08-25
XYcor® Expandable Spinal Spacer System (K160646)Alphatec Spine, Inc.2016-08-24
Kyphon HV-R Bone Cement (K160983)Medtronic, Inc.2016-08-24
ZION Anterior Cervical Fixation System (K160702)Astura Medical2016-08-23
Streamline OCT Occipito-Cervico-Thoracic System (K161498)Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2016-08-22
PathLoc-L MIS Spinal System (K161766)L&K BIOMED Co., Ltd.2016-08-22
Double Medical Universal Spine System (K151458)Double Medical Technology, Inc.2016-08-22
H-Max S stem (K160011)Lima Corporate S.P.A.2016-08-22
Valeo II Interbody Fusion Device System (K161405)Amedica Corp.2016-08-19
Alians Elbow Locking Plating System (K152289)Newclip Technics2016-08-17
Tarsa-Link Stand-Alone Wedge Fixation System (K161037)Life Spine, Inc.2016-08-15
Distal Radius Plating System (K161292)Miami Device Solutions, LLC2016-08-15
RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems (K161210)Medtronic Sofamor Danek2016-08-12
Salto XT, Salto Talaris (K153452)Tornier S.A.S.2016-08-11
Converge (K153573)Biomedical Enterprises, Inc.2016-08-11
Response BandLoc Spinal Fixation (K161267)OrthoPediatrics Corp.2016-08-11
Genesys Spine TiLock Cortical Spinal System (K161914)Genesys Spine2016-08-09
Mont Blanc and Mont Blanc MIS Spinal Systems (K161387)Spineway SA2016-08-04
AFX™ Femoral Implant With Inserter (K161033)Cayenne Medical, Inc.2016-08-03
ARIX Foot System (K161864)Jeil Medical Corporation2016-08-02
Biomet Microfixation Sternal Closure System (K161896)Biomet Microfixation2016-08-02
Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System (K153352)Spinal Elements, Inc.2016-08-01
The Hammertoe Correction System (K153065)Life Spine, Inc.2016-08-01
SpineView X-Pac Expandable Lumbar Cage System (K160856)Spine View, Inc.2016-08-01
VIRTU Lumbar Spacer System (K160699)Met 1 Technologies, LLC2016-08-01
VertiForm Posterior Fixation System (K161499)Next Orthosurgical2016-07-29
MEDINAUT Kyphoplasty System (K153296)Imedicom Co., Ltd.2016-07-29
Cannulated Screw (K161058)Miami Device Solutions, LLC2016-07-29
PASS LP Spinal System (K161627)Medicrea International SA2016-07-29
Genesys Spine Apache® Anchored Cervical Interbody Fusion System (K152099)Genesys Spine2016-07-28
Spinal Elements' Spinous Process Plate System (K160465)Spinal Elements, Inc.2016-07-28
The Progressive Orthopaedic Total Hip System (K151424)The Progressive Orthopaedic Company, LLC2016-07-27
Conventus Orthopaedics Ulna Fixation System (K161048)Conventus Orthopaedics, Inc.2016-07-26
EasyStep (K160813)Stryker GmbH2016-07-26
K2M Growing Spine System (K161028)K2m, Inc.2016-07-22
Tritanium® PL Cage (K160955)Stryker2016-07-21
MectaLIF Anterior Stand-Alone (K160605)Medacta International2016-07-21
EVEREST Spinal System (K161369)K2m, Incorporated2016-07-21
PathLoc-C Posterior Cervical Fixation System (K153439)L&K BIOMED Co., Ltd.2016-07-21
Genesys Spine Apache® Lateral Lumbar Interbody Fusion System (K161404)Genesys Spine2016-07-21
Origin Coxa Vara Hip Stem (K161155)Signature Orthopaedics Pty, Ltd.2016-07-19
DePuy Actis DuoFix Hip Prosthesis (K160907)Depuy(Ireland)2016-07-19
INTRAFIX(TM) Advance Tibial Fastener System (K160804)Medos International SARL2016-07-19
TransContinental® M Spacers and InterContinental® Plate-Spacers (K161223)Globus Medical, Inc.2016-07-15
Threshold™ Pedicular Fixation System (K161694)Spineology, Inc.2016-07-15
NuVasive® VersaTie System (K161265)Nu Vasive, Incorporated2016-07-15
Ascential IBD PEEKc Spacer (K161407)Stryker Spine2016-07-15
Keos Lumbar IBFD (K160631)Keos2016-07-15
ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) (K161668)Conformis, Inc.2016-07-15
Juliet® Ti (K153621)Spineart2016-07-15
Belvedere™ Lateral Plating System (K153097)Neurostructures, Inc.2016-07-15
Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device (K160906)Spineology, Inc.2016-07-14
PROW FUSION-V (K153786)Nlt Spine, Ltd.2016-07-11
PASS OCT Spinal System (K161149)Medicrea International SA2016-07-11
Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula (K152511)Prosurg, Inc.2016-07-11
MLX™ - Medial Lateral Expandable Lumbar Interbody System (K153105)Nu Vasive, Incorporated2016-07-11
AccuLIF TL and PL Cage (K160715)Stryker Corporation2016-07-08
Savannah-T® Pedicle Screw System (K152920)Amendia, Inc.2016-07-08
Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System (K161192)Zimmer GmbH2016-07-08
Alta ACDF System (K152622)Biomet Spine2016-07-08
CorticaLINK Spinal Fusion Platform (K160722)Facetlink Dba Linkspine2016-07-07
Integra External Fixation System (K160830)Ascension Orthopedics2016-07-06
Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm (K160996)Dunamis, LLC2016-07-06
Expedium Spine System, VIPER and VIPER 2 Systems (K160904)Medos International SARL2016-07-01
Cure™ Anterior Cervical Plate (ACP) System (K160604)Meditech Spine, LLC2016-07-01
Arthrosurface Bone Screws (K161539)Arthrosurface, Inc.2016-06-30
MySpine Pedicle Screw Placement Guides - LP (K153273)Medacta International S.A.2016-06-29
Spinal Jaxx Interbody Fusion Device (K152501)Neuropro Spinaljaxx, Inc.2016-06-29
CoRoent® Ti-C System (K160916)Nu Vasive, Incorporated2016-06-28
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