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Orthopedic

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

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RecordFirmDate
Distal Radius Plating System (K182810)Miami Device Solutions, LLC2018-12-10
ICONN Campbell Interference Screw (K180670)Iconn Orthopedics, LLC2018-12-07
C-Zero Pedicle Screw System, Freedom Pedicle Screw System (K180754)Signature Orthopaedics Pty, Ltd.2018-12-07
Avenir Complete Hip System (K182048)Zimmer, Inc.2018-12-07
Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System (K182007)Renovis Surgical Technologies2018-12-07
PATRIOT® Lumbar Spacers, SUSTAIN® Spacers (K181357)Globus Medical, Inc.2018-12-06
EVOLUTION Stemmed CS Femur (K182125)Microport Orthopedics, Inc.2018-12-06
DePuy Synthes T-PAL Spacer System (K181231)Depuy Synthes Spine2018-12-06
MagnetOs Putty (K181958)Kuros Biosciences B.V2018-12-06
Healix™ Compression Screw System (K182949)Nvision Biomedical Technologies, LLC2018-12-04
MectaLIF Posterior Extension (K181970)Medacta International S.A.2018-12-04
V3 Segmental Plating System (K182418)Atlas Spine, Inc.2018-11-29
SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System (K180665)K2m, LLC2018-11-28
NuVasive Reline Fenestrated Screws, High V+ Bone Cement (K180498)Nu Vasive, Incorporated2018-11-28
Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks (K183010)Smith & Nephew, Inc.2018-11-28
SMS Femoral Stem (K181693)Medacta International S.A.2018-11-28
ATEC ALIF and LLIF Spacer System (K182746)Alphatec Spine, Inc.2018-11-27
iFuse Implant System® (K182983)SI-BONE, Inc.2018-11-27
Plateau Spacer System (K182470)Life Spine2018-11-26
TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws (K182346)Exactech, Inc.2018-11-26
Responsive Arthroscopy Interference Screw System (K180573)Responsive Arthroscopy, LLC2018-11-23
HammerTechTM Fixation System (K182684)Fusion Orthopedics, LLC2018-11-23
DePuy Synthes 2.0 mm Quick Insertion Screws (K180541)Synthes USA Products, LLC2018-11-21
SP-LINK™ System (K182352)Medical Designs, LLC2018-11-21
ARIX Sternal System (K181806)Jeil Medical Corporation2018-11-20
NuVasive Monolith Cervical Corpectomy System (K180550)Nu Vasive, Incorporated2018-11-20
R3 Anteverted Liners (K182535)Smith & Nephew, Inc.2018-11-19
REDAPT Modular Acetabular Shell (K182109)Smith & Nephew, Inc.2018-11-16
AdvantageRib Anterior System (K182179)Sig Medical Corp.2018-11-16
Solidity Vertebral Body Replacement (K181921)Ulrich Medical USA2018-11-16
Stratum™ Foot Plating System (K182201)Nextremity Solutions, Inc.2018-11-16
Axis Chena Cervical PEEK Spacer System (K181140)Axis Orthopaedics2018-11-16
YUKON OCT Spinal System (K182182)K2m2018-11-15
PathLoc-L MIS Spinal System (K183117)L&K BIOMED Co., Ltd.2018-11-15
CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control (K182882)Conmed Corporation2018-11-14
Velofix TLIF Cage (K181829)U&I Corporation2018-11-14
ostaPek Interbody Fusion Cages (K181963)Coligne AG2018-11-14
VersaLink™ Fixation System (K182598)Premia Spine, Ltd.2018-11-13
Saxxony™ Posterior Cervical Thoracic System (K182508)Nexxt Spine, LLC2018-11-13
Arco™-SA Lumbar Cage System (K182195)Neurostructures, Inc.2018-11-09
Aspida® Anterior Lumbar Plating System (K182808)Alphatec Spine, Inc.2018-11-09
Neurostructures Cavetto® [MAX] Cervical Cage System (K181590)Neurostructures, Inc.2018-11-08
Exactech Alteon Highly Polished Femoral Stem (K182462)Exactech, Inc.2018-11-08
SMARTRELEASE Endoscopic Soft Tissue Release System (K181819)Microaire Surgical Instruments, LLC2018-11-06
ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thoracolumbar Plate System, PLYMOUTH Thoracolumbar Plate System, SP-Fix Spinous Process Fixation Plate, RELIEVE Laminoplasty Fixation System (K181846)Globus Medical, Inc.2018-11-06
DynaClipTM Bone Staple (K181781)MedShape, Inc.2018-11-05
Spinal Elements Ti-Bond coated devices (K181837)Spinal Elements, Inc.2018-11-02
Panta 2 Arthrodesis Nail System (K181639)Integra LifeSciences Corporation2018-11-02
PRODENSE Bone Graft Substitute (K182823)Wrightmedicaltechnologyinc2018-11-02
Medline Unite Mini Plates and Screws (K181820)Medline Industries, Inc.2018-11-01
DePuy Synthes Trauma Orthopedic Plates and Screws (K180310)Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.2018-11-01
Balanced Knee Revision System Trabecular Tibial Cone Augments (K182085)Ortho Development Corporation2018-10-31
AOS Calcaneal Plating System (K182466)Advanced Orthopaedic Solutions2018-10-30
ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System (K180980)Camber Spine Technologies, LLC2018-10-27
Two-Step Implant System (K181898)Trilliant Surgical2018-10-26
Persona Revision Knee System (K181947)Zimmer, Inc.2018-10-25
SMV Scientific K-Wire and Pins (K182171)Summit Medventures2018-10-25
World Total Knee System (K181530)Signature Orthopaedics Pty, Ltd.2018-10-24
Osteocera Resorbable Bone Substitute (K180758)Wiltrom Corporation Limited2018-10-24
Duo Lumbar Interbody Fusion Device (K182322)Spineology, Inc.2018-10-24
FUSE Pedicle Screw System (K182283)Black Box Medical2018-10-23
Humeral Short Stem System (K173824)Shoulder Innovations, Inc.2018-10-23
ANTHEM Fracture System (K180554)Globus Medical, Inc.2018-10-22
PIP Fix (K181192)Hand Biomechanics Lab, Inc.2018-10-22
Quadra P (K181254)Medacta International S.A.2018-10-22
ICONN Revolution Knotless Suture Anchor (K182264)Iconn Orthopedics, LLC2018-10-19
Titanium TomoFix Medial High Tibia Plate Anatomical (K180213)Synthes (USA) Products, LLC2018-10-19
Stable-C Interbody System (K181621)Nexus Spine, LLC2018-10-19
OLYMPIC Posterior Spinal Fixation System (K182239)Astura Medical, LLC2018-10-18
PASS LP Spinal System (K182240)Medicrea International SA2018-10-17
OsteoBridge™ IDSF System (K181026)Merete GmbH2018-10-17
Depuy Synthes Femoral Neck System (K182154)Synthes (USA) Products, LLC2018-10-16
DynaBridge (K181815)Fusion Orthopedics, LLC2018-10-15
Life Spine Laminoplasty System (K181717)Life Spine, Inc.2018-10-12
BKS Revision Sleeves System (K181569)Ortho Development Corporation2018-10-12
EIT Cellular Titanium® Lumbar Cage LLIF (K181644)Eit Emerging Implant Technologies GmbH2018-10-12
Integra TITAN Reverse Shoulder System (K181999)Integra LifeSciences Corporation2018-10-12
Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap (K182536)Exactech, Inc.2018-10-12
Thorecon Rigid Fixation System (K181607)A & E Medical Corporation2018-10-12
X-BOLT Hip Fracture Fixation System (K181640)X-Bolt Orthopaedics2018-10-12
b-ONE Total Knee System (K180446)B-One Ortho, Corp.2018-10-12
Piccolo Composite® Plate System (K182015)CarboFix Orthopedics , Ltd.2018-10-11
MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate (K182151)Ctl Medical Corporation2018-10-11
AxSOS 3 Ti (K181091)Stryker GmbH2018-10-11
Geminus Volar Distal Radius Plate System (K182492)Skeletal Dynamics, LLC2018-10-10
Cellent Spinal Systems (K172826)Jiangsu Trauhui Medical Instrument Co., Ltd.2018-10-10
Scarlet AL-T (K181818)Spineart2018-10-09
NuVasive Cohere Thoracolumbar Interbody System (K181860)Nu Vasive, Incorporated2018-10-05
SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices (K181531)Spineex, Inc.2018-10-05
EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System (K181603)K2m, Inc.2018-10-05
ORTHOLOC SPS Shoulder Plating System (K181587)Tornier, Inc.2018-10-05
Prase MIS Spinal System (K182059)Gbs Commonwealth Co., Ltd.2018-10-04
WishBone Medical Plate and Screw System (K180736)Wishbone Medical, Inc.2018-10-04
SYMPHONY™ OCT System (K181949)Medos International SARL2018-10-04
ARIX Clavicle System (K180972)Jeil Medical Corporation2018-10-03
Outlet Sacroiliac Joint Fusion System (K181881)Sij Surgical2018-10-03
FIREFLY® Midline Navigation Guide (K181883)Mighty Oak Medical, Inc.2018-10-03
Voyant System (K181885)Viseon, Inc.2018-10-02
MICRORAPTOR Knotless Suture Anchor (K181746)Smith and Nephew, Inc.2018-09-28
Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay (K182039)Arthrex, Inc.2018-09-28
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