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Orthopedic

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

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RecordFirmDate
Y-Knot OneStep Anchor (K193606)Conmed Corporation2020-01-22
Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTC™ Spinal System, Capstone Control™ Spinal System, Capstone Control PTC™ Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ Spinal System, Cornerstone™ PSR Cervical Fusion System, Crescent™ Spinal System, Crescent™ Spinal System Titanium, Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L™ Anterior/Oblique Lumbar Fus (K192502)Medtronic Sofamor Danek USA, Inc.2020-01-22
Nexxt Matrixx System (K193370)Nexxt Spine, LLC2020-01-21
Tyber Medical Anatomical Plating System (K193222)Tyber Medical, LLC2020-01-20
CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System (K193543)In2bones USA, LLC2020-01-17
MobiliT Cup (K191831)Corin U.S.A. Limited2020-01-16
AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip (K192750)Parcus Medical, LLC2020-01-16
ALLthread Titanium Suture Anchor (K192942)Biomet, Inc.2020-01-16
NEX-D2 Posterior Fixation System (K190981)Next Orthosurgical2020-01-15
Arthrex SwiveLock Suture Anchor (K193503)Arthrex, Inc.2020-01-15
SABLE Expandable Spacer (K192115)Globus Medical, Inc.2020-01-14
Streamline TL Spinal Fixation System (K192800)Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2020-01-14
nva, nvp, and nvt (K193645)Nvision Biomedical Technologies, Inc.2020-01-13
CD Horizon™ Fenestrated Screw Set (K193011)Medtronic Sofamor Danek USA, Inc.2020-01-10
Univers Revers Modular Glenoid System (Augemented baseplates) (K193372)Arthrex, Inc.2020-01-10
CorticaLINK Spinal Fusion Platform (K193465)Spine Smith Holdings, LLC2020-01-10
OsteoRemedies Hip Spacer System (K192995)Osteoremedies, LLC2020-01-10
MotoBAND CP Implant System (K193452)Crossroads Extemity Systems, LLC2020-01-10
TrellOss™-L MPF (K192687)Nexxt Spine, LLC2020-01-09
AMIStem-C (K193433)Medacta International S.A.2020-01-09
Tyber Medical Trauma Screws (K192975)Tyber Medical, LLC2020-01-09
Altapore (K192363)Baxter Healthcare Corporation2020-01-09
Genesys Spine 3DP Cervical Interbody System (K191489)Genesys Spine2020-01-08
Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device (K191581)Titan Spine, Inc.2020-01-08
Tyber Medical Trauma Screw (K192974)Tyber Medical, LLC2020-01-08
Avenger Radial Head System (K192754)In2bones USA, LLC2020-01-07
EVOL ha - D Lateral Interbody Fusion System (K192497)Cutting Edge Spine, LLC2020-01-06
Quadra-P (K192827)Medacta International S.A.2020-01-06
TriMed ASET Foot Plating System (K192696)TriMed, Inc.2020-01-05
Conformity stem, cemented (K191056)United Orthopedic Corporation2020-01-03
SureMAX Family of Cervical Spacers (K193359)Additive Implants, Inc.2020-01-03
TunneLoc Tibial Fixation Device (K193092)Biomet, Inc.2020-01-02
InCore TMT System (K192578)Nextremity Solutions, Inc.2019-12-31
Temporary Fixation Pins (K192768)Eisertech, LLC2019-12-26
Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem (K193050)Zimmer GmbH2019-12-26
Arthrex Univers Revers Modular Glenoid System (K191960)Arthrex, Inc.2019-12-23
Mini and Micro Fragments Reconstruction System – GMReis (K182718)Gm Dos Reis Industria E Comerico Ltda.2019-12-23
Trigon™ Ti Stand-Alone Wedge Fixation System (K192645)Nvision Biomedical Technologies, Inc.2019-12-23
Acetabular Bone Screws (for MobileLink Acetabular Cup System) (K192559)Waldemar Link GmbH & Co. KG2019-12-21
Bengal Stackable Cage System (K190284)Medos International SARL2019-12-20
NanoOrtho NanoKnee® System (K190633)Nanoortho, LLC2019-12-20
Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology (K192718)Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.2019-12-20
SX-One MicroKnife (K192873)Sonex Health, Inc.2019-12-20
4CIS Marlin PEEK ACIF Cage (K192044)Solco Biomedical Co., Ltd.2019-12-19
Avenir Complete Hip System, Size 0 Coxa Vara (K192189)Zimmer, Inc.2019-12-18
Percusys® Plus Pedicle Screw System (K192680)Joimax GmbH2019-12-18
G Surgical Marksman System (K193219)G Surgical, LLC2019-12-17
Precision Casting Solutions Total Hip System (K192450)Precision Casting Solution, LLC2019-12-17
Stand-Alone ALIF Titanium System (K191834)Life Spine, Inc.2019-12-16
Pantheon Spinal Pontus Interbody Fusion Device (K181548)Pantheon Spinal2019-12-16
Keos Lumbar IBFD (K193174)Keos2019-12-16
Airlock Centrolock Osteosynthesis Implant System (K192356)Novastep2019-12-14
MyShoulder Placement Guides (K190738)Medacta International S.A.2019-12-13
Neo Cage System (K191796)Neo Medical SA2019-12-13
Avanti Distal Radius and Forearm System (K191118)Avanti Orthopaedics, Inc.2019-12-13
Genesys Spine 3DP Lumbar Interbody System (K182987)Genesys Spine2019-12-12
Arthrex 3.9mm Corkscrew Suture Anchor (K193157)Arthrex, Inc.2019-12-12
Invictus™ Spinal Fixation System (K192938)Alphatec Spine, Inc.2019-12-12
LOSPA II Knee System (K192507)Corentec Co., Ltd.2019-12-11
Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System (K191793)Nebula Surgical Private Limited2019-12-09
Avenir Muller Stem, Avenir Cemented Hip Stem (K193030)Zimmer GmbH2019-12-06
Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings (K190656)Zimmer, Inc.2019-12-06
BC Reflex Uni Knee System (K191996)Bodycad Laboratories, Inc.2019-12-05
G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E Highly Crosslinked Polyethylene (K190660)Zimmer, Inc.2019-12-05
TRACKER Kyphoplasty System (K192335)GS Medical Co., Ltd.2019-12-04
SeaSpine Beachside System (K192132)SeaSpine Orthopedics Corporation2019-12-03
M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System (K193083)Medacta International S.A.2019-12-03
Exsomed Wrist Plating System (K192473)Exsomed Corporation2019-12-03
Hi-Fatigue Bone Cement (K192394)Osartis GmbH2019-12-02
Integra TITAN Reverse Shoulder System (K190588)Integra LifeSciences Corporation2019-12-02
Resorbable Mesh Device (K193040)SeaSpine Orthopedics Corporation2019-11-30
Shoulder Innovations Total Shoulder System (K192365)Shoulder Innovations, Inc.2019-11-29
Hi-Fatigue G Bone Cement (K192379)Osartis GmbH2019-11-27
World Knee Total Knee Systems (K190577)Signature Orthopaedics Pty, Ltd.2019-11-27
DePuy Synthes Trauma Screws (K192745)Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.2019-11-26
Peridot Intervertebral body fusion System (K192026)Gbs Commonwealth Co., Ltd.2019-11-26
Streamline MIS Spinal Fixation System (K192396)Pioneer Surgical Technology, Inc.2019-11-26
DePuy Corail AMT Hip Prosthesis (K192946)DePuy Orthopaedics, Inc.2019-11-26
Pinnacle Duofix HA Acetabular Cup Prosthesis (K192919)DePuy Orthopaedics, Inc.2019-11-26
FiberTak Button (K191426)Arthrex, Inc.2019-11-26
Physica KR Liner and SMR Reverse Humeral Liner (K190911)Limacorporate2019-11-26
ARIX Cannulated Screw System (K192417)Jeil Medical Corporation2019-11-26
Cortina™ [MAX] Lumbar Cage System (K192248)Neurostructures, Inc.2019-11-25
VariAx Foot (K192675)Stryker GmbH2019-11-22
Parcus Synd-EZ SS (K192964)Parcus Medical, LLC2019-11-22
SMR TT Augmented Glenoid System (K191746)Lima Corporate S.P.A.2019-11-22
AMIStem-P Short Neck (K192126)Medacta International S.A.2019-11-22
Axis Plating System (K192592)Extremity Medical, LLC2019-11-21
Engage™ Partial Knee System (K190439)Engage Uni, LLC2019-11-21
TranS1 AxiaLIF Plus System (K192792)Trans12019-11-20
PolyLock Small Bone Plating System (K192323)Fusion Orthopedics, LLC2019-11-18
TDM Plate and Screw Systems (K190391)Tdm Co., Ltd.2019-11-15
SmartSPACE Shoulder System (K191247)Techmah Medical, LLC2019-11-15
LongBow Ti (K190721)Life Spine, Inc.2019-11-14
EBA One Nailing System (K183666)Citieffe S.R.L.2019-11-14
NuVasive CoRoent Small Interlock System (K192582)Nu Vasive, Incorporated2019-11-13
GMA 2.0 Pedicle Screw System (K192915)Grafton Medical Alliance2019-11-13
AEON-C Stand Alone System (K191477)Huvexel Co. , Ltd.2019-11-13
ARIX Wrist System (K191972)Jeil Medical Corporation2019-11-12
APTUS Wrist Arthrodesis Plates (K192297)Medartis AG2019-11-08
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