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Orthopedic

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

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RecordFirmDate
IRENE Thoracolumbar Fixation System (K172267)Tianjin Zhengtian Medical Instrument Co., Ltd.2018-03-06
OrthoSteady G Bone Cement (K173494)G21, S.R.L.2018-03-06
Valeo® C+CSC with Lumen Interbody Fusion Device (K173453)Amedica Corp.2018-03-05
LEGION Knee System (K180334)Smith & Nephew, Inc.2018-03-05
EMPOWR Universal Tibial Baseplate (K173723)Encore Medical L.P.2018-03-05
DePuy Synthes Femoral Neck System (K172872)DePuy Synthes2018-03-05
HammerTube System (K171715)Paragon 282018-03-05
Footmotion HammerToe (K172485)Newclip Technics2018-03-02
PUMA System (K171703)Panther Orthopedics, Inc.2018-03-01
Arthrex Corkscrew FT (K173788)Arthrex, Inc.2018-03-01
ALTA Anterior Cervical Interbody Spacer (K173324)Astura Medical2018-02-27
Activmotion Range (K173746)Newclip Technics2018-02-27
TRYPTIK2 C-Plate Anterior Cervical Plate System (K171797)Spineart2018-02-26
Neurostructures Cavetto® Cervical Cage System (K172320)Neurostructures, Inc.2018-02-26
Cavetto-SA Cervical Cage System (K173077)Neurostructures, Inc.2018-02-23
RTS Lesser MTP Implant System (K173491)In2bones USA, LLC2018-02-23
ELEOS™ Bipolar Acetabular System (K180130)Onkos Surgical, Inc.2018-02-23
Orbitum Bone Staple Implant, X and VI (K173693)Orthovestments, LLC2018-02-23
Talon DistalFix Humeral Nail (K173255)Orthopedic Designs North America, Inc.2018-02-22
Osteotomy Truss System (OTS) (K172294)4Web, Inc.2018-02-22
Remedy Acetabular Cup (K173967)Osteoremedies, LLC2018-02-22
SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty (K171568)Hans Biomed Corporation2018-02-22
SeaSpine Spinous Process System (K173334)SeaSpine Orthopedics Corporation2018-02-22
SeaSpine NewPort Spinal System (K180176)SeaSpine Orthopedics Corporation2018-02-20
SEURAT™ Universal Pedicle Screw System (K173185)Ctl Medical Corporation2018-02-14
Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device (K173535)Titan Spine, LLC2018-02-13
MotoBAND CP Implant System (K173710)Crossroads Extremity Systems, LLC2018-02-12
Thorecon™ Fixation System (K173579)A & E Medical Corporation2018-02-12
Zyston Strut Open Titanium Spacer System (K171495)Zimmer Biomet Spine, Inc.2018-02-12
Arthrex NanoSuture Anchor (K180118)Arthrex, Inc.2018-02-12
CASCADIA Interbody System (K172941)K2m2018-02-12
Comprehensive Segmental Revision System (SRS) (K173411)Biomet Manufacturing Corp2018-02-08
CONCORDE LIFT™ (K173537)Medos International SARL2018-02-08
NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP Expandable XLIF System (K173025)Nu Vasive, Incorporated2018-02-08
THP Hip Fracture Plating System (K173826)Biomet, Inc.2018-02-07
G-Beam Fusion Beaming System (K172698)Orthofix Srl2018-02-07
SeaSpine Mariner Pedicle Screw System (K173882)SeaSpine Orthopedics Corporation2018-02-06
Bicera Resorbable Bone Substitute (K172237)Wiltrom Corporation Limited2018-02-02
The Plateau-LO Spacer System (K172105)Life Spine, Inc.2018-02-02
Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage (K173800)Camber Spine Technologies2018-02-02
Materialise TKA Guide System (K173445)Materialise NV2018-02-02
Triathlon Total Knee System (K173849)Stryker Orthopaedics2018-02-02
The Solstice OCT System (K173047)Life Spine, Inc.2018-02-01
ABCcolla Bone Graft (K171629)Acro Biomedical Co., Ltd.2018-02-01
Double Medical Cage System (K172828)Double Medical Technology, Inc.2018-02-01
Zimmer Persona Personalized Knee System (K173417)Zimmer, Inc.2018-01-30
40-42mm BiPolar Head and 22mm Femoral Head (K163081)Signature Orthopaedics Pty, Ltd.2018-01-29
DeGen Medical E3 MIS Pedicle Screw System (K173814)Degen Medical2018-01-29
TiGer Shark™ System (K172816)Choicespine, LP2018-01-26
Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) (K172116)Stryker Corporation2018-01-25
SeaSpine Cabo ACP (Anterior Cervical Plate) System (K173521)SeaSpine Orthopedics Corporation2018-01-24
ARROW Reverse Porous Glenoid (K171789)Fournitures Hospitalieres Industrie2018-01-23
Centurion POCT System (K180025)Orthofix, Inc.2018-01-22
EZ Plate (K173306)Zavation Medical Products, LLC2018-01-22
FortiCore® (K171312)Nanovis, LLC2018-01-22
BioSphere MIS Putty (BioSphere MIS) (K173301)Synergy Biomedical, LLC2018-01-19
Reliance Lumbar IBF System (K173283)Reliance Medical Systems, LLC2018-01-19
DIP Arthrodesis System (K173616)In2bones Sas2018-01-19
FORZA® XP Expandable Spacer System (K172696)Orthofix, Inc.2018-01-19
Fiji Anchor (K171228)Sportwelding GmbH2018-01-19
LINK® BiMobile(TM) Dual Mobility System (K171273)Waldemar Link GmbH & Co. KG2018-01-19
GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert (K173875)Stelkast, Inc.2018-01-19
Choice Spine Laminoplasty™ Fixation System (K173215)Choicespine, LP2018-01-19
FMS VUE II Fluid Management and Tissue Debridement System (K171237)Medos International SARL2018-01-18
Tritanium® TL Curved Posterior Lumbar Cage (K173476)Stryker2018-01-18
Unity Total Knee System (K173884)Corin U.S.A. Limited2018-01-17
Arthrex PushLock (K173240)Arthrex, Inc.2018-01-16
Activ Ankle (K173641)Newclip Technics2018-01-16
Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt (K172189)Truemed Group, LLC2018-01-16
ARBOR External Fixation System (K172438)Globus Medical, Inc.2018-01-12
T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System (K172774)Stryker Trauma GmbH2018-01-12
HBS2 Headless Bone Screw (K171628)Stuckenbrock Medizintechnik GmbH2018-01-12
Wiltrom Spinal Fixation System (K172548)Wiltrom Corporation Limited2018-01-12
GLOBAL UNITE Platform Shoulder System (K170748)Depuy Ireland UC2018-01-11
ExoToe Staple (K172205)Exotoe, LLC2018-01-11
Smith & Nephew Patient Matched Cutting Blocks (K172336)Smith & Nephew, Inc.2018-01-10
VERTICALE® Posterior Spinal Fixation System/VERTICALE® System (K171421)Silony Medical GmbH2018-01-10
MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ (K172212)Ctl Medical Corporation2018-01-09
Guided Growth Plate System Plus (K172183)Orthofix Srl2018-01-09
Everest Spinal System (K173508)K2m2018-01-09
Cervical Spinal Truss System (CSTS) Interbody Fusion Device (K173159)4Web, Inc.2018-01-08
EVOS Small Fragment Upper Extremity Plates (K173293)Smith & Nephew, Inc.2018-01-08
ToggleLoc System (K173278)Biomet, Inc.2018-01-05
Bone Screws 6.5mm (K172456)Lima Corporate S.P.A.2018-01-04
Alians Elbow Locking Plating System (K171372)Newclip Technics2018-01-04
Juliet Ti LL (K173702)Spineart2018-01-03
Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate (K172502)Biomet Manufacturing Corp2018-01-03
AUTOBAHN Nailing System (K171108)Globus Medical, Inc.2017-12-29
Reliance Cervical IBF System (K173102)Reliance Medical Systems, LLC2017-12-29
Osteo-P Bone Graft Substitute (K170165)Molecular Matrix, Inc.2017-12-29
Piccolo Composite Nailing System (K173652)CarboFix Orthopedics , Ltd.2017-12-28
X-PSI Knee System (K171269)Orthosoft Inc (D/B/A Zimmer Cas)2017-12-28
AltiVate Anatomic to Reverse Conversion Module (K173073)Encore Medical L.P.2017-12-26
SCS 17-01 (K173008)Anika Therapeutics, Inc.2017-12-26
CONQUEST FN (K172785)Smith & Nephew2017-12-22
Arthrosurface Bone Screws (K172383)Arthrosurface, Inc.2017-12-22
Align Radial Head System (K172688)Skeletal Dynamics, LLC2017-12-22
Blustone Synergy Silica System (K172330)Blustone Synergy2017-12-21
FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO Corpectomy Spacers, SUSTAIN Spacers, COALITION Spacers, PATRIOT Lumbar Spacers, PATRIOT Cervical Spacers, ALTERA Spacers, RISE Spacers, CALIBER Spacers, ELSA Spacers, LATIS Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, MAGNIFY Spacers, INDEPENDENCE Spacers (K171848)Globus Medical, Inc.2017-12-21
Life Spine Foot and Ankle Plating System (K172973)Life Spine, Inc.2017-12-21
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