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Orthopedic

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

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RecordFirmDate
Lumbar Interbody Fusion System (OLLIF) (K173947)Advanced Research Medical, LLC2018-07-25
FIREFLY® Pedicle Screw Navigation Guide (K181399)Mighty Oak Medical, Inc.2018-07-24
DePuy Synthes Static Staples (K180544)Synthes (USA) Products, LLC2018-07-24
Altus Spine Pedicle Screw System (K181339)Altus Partners, LLC2018-07-24
JASPER Spinal Fixation System (K173645)Gbs Commonwealth Co., Ltd.2018-07-23
Stryker All-PEEK Knotless Anchor System (K181083)Stryker2018-07-23
JGH1 Core Deccompression Procedure Kit (K181585)AgNovos Healthcare USA, LLC2018-07-20
Athena Cervical Plate System (K180022)Medyssey USA, Inc.2018-07-20
EcoFit Vit E Acetabular System (K180263)Implantcast GmbH2018-07-20
CuffLink Implant System Biocomposite (K180763)Conmed Corporation2018-07-19
Latitud Hip Replacement System (K172857)Meril Healthcare Pvt. , Ltd.2018-07-19
JGH1 Bone Graft Substitute (K181342)AgNovos Healthcare USA, LLC2018-07-19
SeaSpine Regatta Lateral System (K181079)SeaSpine Orthopedics Corporation2018-07-18
Tritanium PL Cage (K181014)Stryker Spine2018-07-18
CarboClear® Pedicle Screw System (K173487)CarboFix Orthopedics , Ltd.2018-07-18
Apex Femoral Nailing System (K181375)Orthoxel2018-07-17
Rubicon Lumbar Interbody Fusion System (K181030)Rubicon Spine, LLC2018-07-17
Field Orthopaedics Micro Screw System (K180348)Field Orthopaedics Pty, Ltd.2018-07-17
CxHA PEEK Cervical IBF System (K181115)Innovasis, Inc.2018-07-16
PathLoc-SI Joint Fusion System (K181600)L&K BIOMED Co., Ltd.2018-07-16
Kestrel™ Buttress Plate System (K181063)Innovasis, Inc.2018-07-13
Injection Screw (K173556)Biedermann Medtech, Inc.2018-07-13
Normandy VBR System (K180673)Zavation Medical Products, LLC2018-07-13
Viking Lumbar Polyaxial Screw System (K180655)Presidio Surgical2018-07-13
FBC 921 (ALIF) (K180695)Fbc Device Aps2018-07-12
Catalyst CSR Shoulder System (K181287)Catalyst Orthoscience, Inc.2018-07-12
INVISION Total Ankle Revision System (K180730)Wrightmedicaltechnologyinc2018-07-11
SALVATION Midfoot Nail (K180024)Wrightmedicaltechnologyinc2018-07-11
ROCCIA ALIF, ROCCIA TLIF (K180963)Silony Medical GmbH2018-07-11
Zavation IBF System (K181246)Zavation Medical Products, LLC2018-07-10
Zavation Cervical Plate System (K181244)Zavation Medical Products, LLC2018-07-10
Curiteva Cervical Interbody Fusion System (K181261)Curiteva, LLC2018-07-09
Prime Acetabular Cup System (K180798)Microport Orthopedics, Inc.2018-07-09
EMPOWR VVC TIBIAL INSERT (K180930)Encore Medical L.P.2018-07-09
Materialise PKA Guide System (K173970)Materialise NV2018-07-06
ASTRA-OCT Spine System (K181350)Spinecraft, LLC2018-07-06
Vail ALIF Buttress Plate System (K180755)Evolution Spine, LLC2018-07-06
Tyber Medical PT Interbody Spacer System (K180590)Tyber Medical, LLC2018-07-06
OLYMPIC Posterior Spinal Fixation System (K181139)Astura Medical, LLC2018-07-06
BIOLOX delta Option and Extra-long Heads (K173776)Microport Orthopedics, Inc.2018-07-06
Peekplus® Interbody Fusion Device (K173864)Vallum Corporation2018-07-02
CREO® Stabilization System, REVERE® Stabilization System (K181068)Globus Medical, Inc.2018-06-29
MotoCLIP/HiMAX Implant System (K181410)Crossroads Extremity Systems, LLC2018-06-29
Juliet Ti (K181203)Spineart2018-06-28
HD LifeSciences Cervical IBFD System (K180364)Hd Lifesciences, LLC2018-06-27
Range (Denali and Mesa) Spinal Systems (K181119)K2m, Inc.2018-06-26
EVOL® ha-C Cervical Interbody Fusion System (K180674)Cutting Edge Spine, LLC2018-06-25
SPIRA Open Matrix LLIF (K180724)Camber Spine Technologies, LLC2018-06-25
MONET™ Anterior Cervical Interbody Fusion Cage System (K172788)Ctl Medical Corporation2018-06-25
A3 Total Knee System (K180493)Beijing AK Medical Co., Ltd.2018-06-22
Life Spine Lumbar Fixation System (SENTRY) (K180166)Life Spine, Inc.2018-06-22
Knotless SutureTak Anchors (K180594)Arthrex, Inc.2018-06-22
DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional (K172975)Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.2018-06-21
Integra TITAN Reverse Shoulder System (K173717)Integra LifeSciences Corporation2018-06-21
Fracture and Correction System (K180377)In2bones USA, LLC2018-06-20
Cartiva SCI Disposable Instrumentation Set (K181348)Cartiva, Inc.2018-06-20
Balanced Knee Revision System - Offset Junction Box (K180743)Ortho Development Corporation2018-06-20
CoLink™ Afx Plating System (K181113)In2bones USA, LLC2018-06-15
Trinity PLUS Acetabular Shell (K172551)Corin U.S.A. Limited2018-06-15
Life Spine SIMPACT Sacroiliac Joint Fixation System (K180749)Life Spine, Inc.2018-06-15
Patello-Femoral Wave (Kahuna) Arthroplasty System (K181280)Arthrosurface, Inc.2018-06-14
TiWAVE-C™ Porous Titanium Cervical Cage (K180401)Kalitec Direct, LLC2018-06-14
SurgTech Bipolar Head System (K173455)Surgtech, Inc.2018-06-14
S128 Anterior Lumbar Interbody Fusion (ALIF) System (K180502)Renovis Surgical Technologies, Inc.2018-06-14
Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) (K180818)Tenon Medical, Inc.2018-06-13
Atlas Spine Expandable Cervical Interbody System (K180675)Atlas Spine, Inc.2018-06-13
E-XPE Acetabular Components and U-Motion II Acetabular Cup (K172833)United Orthopedic Corporation2018-06-12
X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F CAGE® System (K173787)Medos International SARL2018-06-11
Endiscope, Endiscope Cervical (K180766)Elliquence, LLC2018-06-11
Altus Spine Pedicle Screw System (K181281)Altus Partners, LLC2018-06-11
Lumfuse TP (K173189)Precifit Medical, Ltd.2018-06-08
Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts (K180612)Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2018-06-07
T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System (K180436)Stryker Trauma GmbH2018-06-06
SALVATION External Fixation System (K180832)Wrightmedicaltechnologyinc2018-06-06
VariAx 2 System (K180500)Stryker GmbH2018-06-04
Sternal Cable System (K180582)A & E Medical Corporation2018-05-31
Single Use Arthroscopic Electrode (with Pencil) (K170703)Modern Medical Equipment Manufacturing Limited2018-05-31
ATEC Universal Spacer System (K180480)Alphatec Spine, Inc.2018-05-31
AEVUMED PHANTOM Suture Anchors (K180464)Aevumed, Inc.2018-05-31
EVEREST Spinal System (K181188)K2m, Inc.2018-05-30
Legend Acetabular Liners (K173951)Ortho Development Corporation2018-05-30
KATOR Suture Anchor (K173269)Kator, LLC2018-05-30
MICRORAPTOR REGENESORB Suture Anchor (K180361)Smith and Nephew, Inc.2018-05-30
SpineKure Kyphoplasty System (K172871)Hanchang Co., Ltd.2018-05-29
PATRIOT COLONIAL Spacer, SUSTAIN Spacer (K173722)Globus Medical, Inc.2018-05-23
AlignX Ankle Fusion System (K181067)Extremity Medical, LLC2018-05-23
Omni Foot Plating System (K180808)Extremity Medical, LLC2018-05-22
Arthrex FastThread Interference Screw (K180662)Arthrex, Inc.2018-05-22
AERIAL™ Interspinous Fixation (K180817)Globus Medical, Inc.2018-05-21
SAGICO OSI Spinal System by Osimplant (K180220)Spinal Analytics & Geometrical Implant Co, LLC2018-05-21
KYPHON HV-R Bone Cement (K180700)Medtronic Sofamor Danek USA, Inc.2018-05-18
A.M. Surgical Intramedullary Fixation Device (K180087)A.M. Surgical, Inc.2018-05-18
DTRAX Spinal System (K180876)Providence Medical Technology, Inc.2018-05-18
icotec Interbody Cage System (K172480)Icotec AG2018-05-17
Zimmer Persona Personalized Knee System (K172524)Zimmer, Inc.2018-05-17
InTice™-C Porous Ti Cervical Interbody System (K173832)X-Spine Systems, Inc.2018-05-17
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System (K180906)Conformis, Inc.2018-05-16
Additive Orthopaedics Patient Specific 3D Printed Bone Segments (K180239)Additive Orthopaedics, LLC2018-05-16
HARRIER-SA™ Lumbar Interbody System (K180519)Choicespine, LP2018-05-16
Reliance Lumber IBF System (K180687)Reliance Medical Systems2018-05-15
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