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Orthopedic

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

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RecordFirmDate
Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device (K183557)Titan Spine, Inc.2019-02-11
Cemented TSI Hip Stem (K181340)Signature Orthopaedics Pty, Ltd.2019-02-11
SMG Anterior Cervical Plate System (K183073)Sapphire Medical Group2019-02-11
LINK MP Monoblock Hip Prosthesis (K183141)Waldemar Link GmbH & Co. KG2019-02-08
Biomet Headless Compression and Twist-Off Screws (K190035)Biomet, Inc.2019-02-07
Parcus GFS BTB (K183331)Parcus Medical, LLC2019-02-07
Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™ Anterior Cervical Plate, Venture™ Anterior Cervical Plate, Zephir™ Anterior Cervical Plate System and Zevo™ Anterior Cervical Plate System (K182885)Medtronic Sofamor Danek USA, Inc.2019-02-06
SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments (K183119)Globus Medical, Inc.2019-02-06
Omnia Medical Rotary PLIF System (K183659)Omnia Medical, LLC2019-02-06
PRECICE® BONE TRANSPORT™ System (K182170)Nuvasive Specialized Orthopedics, Inc.2019-02-05
Velofix Interbody Fusion System (K190067)U&I Corporation2019-02-04
EIT Cellular Titanium Lumbar Cage - T/PLIF (K183447)Eit Emerging Implant Technologies GmbH2019-02-04
Pedimax II - Pedicular Screw Spinal System (K180626)Gm Dos Reis Industria E Comerico Ltda.2019-02-01
SECULOK™ ACP System (K190053)U&I Corporation2019-02-01
Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid (K183696)Tornier, Inc.2019-01-30
Zimmer Segmental System Proximal Femoral Component (K183136)Zimmer, Inc.2019-01-30
MOTO Partial Knee System (K183029)Medacta International S.A.2019-01-30
Neo Cage System TM (K181048)Neo Medical SA2019-01-29
Cervical Spacer (K182477)Additive Implants, LLC2019-01-28
MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component (K183025)B-One Ortho, Corp.2019-01-28
VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System (K180822)Wenzel Spine, Inc.2019-01-28
Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow (K181307)Zimmer, Inc.2019-01-28
NEST Interbody System (K180230)Paonan Biotech Co., Ltd.2019-01-25
Hoffmann LRF System (K182968)Stryker GmbH2019-01-25
Treace Medical Concepts (TMC) Plating System (K183321)Treace Medical Concepts, Inc.2019-01-25
SI-Restore® Sacroiliac Joint Fixation System (K182919)Biofusion Medical2019-01-25
SMR Lateralized Connectors with screws (K183042)Lima Corporate S.P.A.2019-01-25
HammerToe Compression System (K183228)Paragon 28, Inc.2019-01-25
EZStart Interference Screw (K182955)Conmed Corporation2019-01-22
Freedom Ultra-Congruent CR Tibial Liner (K182574)Maxx Orthopedics, Inc.2019-01-22
M.U.S.T. Mini Extension (K182837)Medacta International S.A.2019-01-22
EUROPA™ Pedicle Screw System (K182970)MiRus, LLC2019-01-22
Compress and Mini Compress Anti-Rotation Spindles (K183553)Biomet, Inc.2019-01-22
Tigon Medical Tissue Anchors (K182507)Tigon Medical2019-01-21
Tyber Medical PT Interbody Spacer (K182284)Tyber Medical, LLC2019-01-18
Responsive Arthroscopy Wedge Push-In Suture Anchors (K181076)Responsive Arthroscopy, LLC2019-01-18
Bodycad Unicompartmental Knee System (K181302)Bodycad Laboratories, Inc.2019-01-17
Pinehurst Anterior Cervical Plate System (K181190)Signature Orthopaedics Pty, Ltd.2019-01-17
Imboki Knee Instrument System (K181338)Signature Orthopaedics Pty, Ltd.2019-01-17
CervAlign™ Anterior Cervical Plate System (K183060)Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2019-01-17
T2 STRATOSPHERE Expandable Corpectomy System (K183510)Medtronic Sofamor Danek USA, Inc.2019-01-16
4CIS® Pinehurst Anterior Cervical Plate system (K182489)Solco Biomedical Co., Ltd.2019-01-16
Estremo Citieffe Nailing System (K181540)Citieffe S.R.L.2019-01-16
Pristine Scope (K183165)Pristine Surgical2019-01-16
Avenue P Cage System (K181096)Zimmer Biomet Spine, Inc.2019-01-15
Whistler Modular Pedicle Screw System (K182478)Evolution Spine, LLC2019-01-15
TenoTac Soft Tissue Fixation System (K182898)Paragon 28, Inc.2019-01-14
Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System (K182307)Paragon 28, Inc.2019-01-14
Catalyst CSR Press-Fit Humeral Components (K182500)Catalyst Orthoscience, Inc.2019-01-11
CD Horizon™ Spinal System (K182928)Medtronic Sofamor Danek USA, Inc.2019-01-11
PROSTEP MICA Screw System (K181377)Wrightmedicaltechnologyinc2019-01-11
II-Type Intervertebral Spacer (K180228)Paonan Biotech Co., Ltd.2019-01-11
Geo Staple System (K182212)Gramercy Extremity Orthopedics, LLC2019-01-11
VLIFT-s Vertebral Body Replacement System (K183071)Stryker Spine2019-01-10
Additive Orthopaedics Patient Specific 3D Locking Lattice Plates (K183011)Additive Orthopaedics2019-01-10
OSSIO™ Pin Product Family (K181180)OSSIO , Ltd.2019-01-10
Cortical Fixation Systems (K181086)Cousin Biotech Sas2019-01-09
G3A 40 Bone Cement (K181282)G21, S.R.L.2019-01-09
Reliance Lumbar IBF System (K181118)Reliance Medical Systems2019-01-09
TruShot with Y-Knot Shallow All-Suture Anchor (K182439)Conmed Corporation2019-01-08
FlareHawk Interbody Fusion System (K182114)Integrity Implants, Inc.2019-01-07
Precision Ideal Eyes Arthroscopes (K183470)Stryker2019-01-07
TiWAVE-L Porous Titanium Lumbar Cage (K182210)Kalitec Medical, LLC2019-01-07
CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver (K182621)Conmed Corporation2019-01-04
Responsive Arthroscopy Suture Anchor System (K180951)Responsive Arthroscopy, LLC2019-01-03
Raven Lumbar Plate System (K183214)Choicespine, LP2019-01-03
OIC Suture Anchor System (K182736)The Orthopaedic Implant Company2018-12-28
LATITUDE EV Total Elbow Arthroplasty (K182461)Tornier, Inc.2018-12-27
Zimmer Biomet Select Ceramic Heads (K181761)Zimmer, Inc.2018-12-26
DePuy Synthes Trauma Orthopedic Nail Implants (K182783)DePuy Synthes2018-12-26
Delta TT Pro (K182099)Lima Corporate S.P.A.2018-12-26
Arthrex Fracture Adapter Hemi Shoulder Prosthesis (K181555)Arthrex, Inc.2018-12-21
TruMatch Graft Cage - Long Bone (K180821)Synthes (Usa), LLC2018-12-21
Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) (K181752)Stryker Corporation2018-12-21
2.8 mm/3.3 mm PopLok Suture Anchors (K181120)Conmed Corporation2018-12-21
FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute (K182670)Prosidyan, Inc.2018-12-20
Curiteva Lumbar Interbody Fusion System (K181589)Curiteva, LLC2018-12-20
TruShot with Y-Knot All-Suture Anchor (K182446)Conmed Corporation2018-12-19
CoreLink F3D™ Lateral System (K183239)Corelink, LLC2018-12-19
REVEL Spacers (K180909)Globus Medical, Inc.2018-12-18
Integra Salto Total Ankle System (K182878)Ascension Orthopedics2018-12-18
AURORA™ Screw System (K182989)MiRus, LLC2018-12-18
Arthrex Compression FT Screws (K182361)Arthrex, Inc.2018-12-18
Met One Czar Anterior Cervical Plate System (K180772)Met One Technologies2018-12-17
Arthrex SwiveLock Anchors (K180768)Arthrex, Inc.2018-12-14
Affixus Hip Fracture Nail (K183162)Biomet, Inc.2018-12-14
Affixus Natural Nail System Humeral Nail (K181827)Zimmer GmbH2018-12-14
ROCCIA® PLIF (K181899)Silony Medical GmbH2018-12-13
CBT Screw Fixation System (K181824)U&I Corporation2018-12-13
IlluminOss Photodynamic Bone Stabilization System (K183145)Illuminoss Medical, Inc.2018-12-13
ANAX™ OCT Spinal System (K183383)U&I Corporation2018-12-12
Salvo™ Spine System (K182954)Spine Wave, Inc.2018-12-12
LEUCADIA AUTOLOK™ Pedicle Screw System (K182339)Clearview Orthopedic Development, LLC2018-12-12
PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems (K182473)K2m, Inc.2018-12-12
OpenLoc-L Spinal Fixation System (K183168)L&K BIOMED Co., Ltd.2018-12-11
Life Spine Resolute™ Threaded Cage System (K181625)Life Spine, Inc.2018-12-11
BI-MENTUM dual mobility system (K181744)Serf2018-12-11
Glenoid Polyaxial Non-locking Screws (K181826)Medacta International S.A.2018-12-10
Mega Plus Spine System (K183080)Bk Meditech, Co., Ltd.2018-12-10
Lucent® XP (K182584)Spinal Elements, Inc.2018-12-10
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