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Orthopedic

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

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RecordFirmDate
Ali Interbody Fusion System (K191516)Raed M. Ali, M.D., Inc.2019-09-12
MectaLock Ti Suture Anchor (K191300)Medacta International S.A.2019-09-12
Catalyst OrthoScience CSR Shoulder System (K191811)Catalyst Orthoscience, Inc.2019-09-11
Ti3Z Cervical Interbody System (K191354)Zavation Medical Products, LLC2019-09-09
TTC Phantom Intramedullary Nail System (K191782)Paragon 28, Inc.2019-09-06
Persona Revision Knee System (K191625)Zimmer, Inc.2019-09-05
Freedom Primary PCK (K192148)Maxx Orthopedics, Inc.2019-09-05
Smith & Nephew DYONICS 25 Fluid Management System (K192155)Smith & Nephew, Inc.2019-09-04
Cartiva SCI instrumentation set (K192156)Cartiva, Inc.2019-09-04
Syntec Tibial Nail System (K191617)Syntec Scientific Corporation2019-09-03
NuVasive® ACP System (K191500)Nu Vasive, Incorporated2019-09-03
Triton Cage (K183407)Medyssey USA, Inc.2019-08-30
iNSitu Total Hip System (K192071)Theken Companies, LLC2019-08-30
Signature ONE System (K192074)Orthosoft Inc (D/B/A Zimmer Cas)2019-08-30
Cyclops™ Anterior Cervical Plate System (K191786)Degen Medical, Inc.2019-08-30
Endoskeleton TAS Plate (K192054)Titan Spine, Inc.2019-08-29
Binary® Anterior Cervical Plate System (K192076)Genesys Spine2019-08-29
Dunamis Fixation Button System (K191319)Dunamis, LLC2019-08-29
Curiteva Pedicle Screw System (K191810)Curiteva, Inc.2019-08-28
Conformis BeneFIT Hip System (K190904)Conformis, Inc.2019-08-28
Omnia Medical VBR (K191778)Omnia Medical, LLC2019-08-28
Implantcast ic-Bipolar Head System (K191569)Implantcast GmbH2019-08-28
EXETER Centralizer, EXETER 2.5mm Plug (K191414)Stryker Orthopaedics2019-08-28
BIOLOX CONTOURA Ceramic Femoral Head (K191399)Total Joint Othopedics, Inc.2019-08-28
Signature Ceramic Femoral Head (K190704)Signature Orthopaedics Pty, Ltd.2019-08-28
Interphalangeal Joint Fusion Device Range (K191424)Neosteo2019-08-28
VariAx 2 System, VariAx 2 Mini Fragment System (K191412)Stryker GmbH2019-08-23
Libertas – Taper Uncemented Femoral Stem (K183684)Maxx Orthopedics, Inc.2019-08-23
REMEDY Acetabular Cup (K191981)Osteoremedies, LLC2019-08-23
Rampart™ One Lumbar Interbody Fusion System (K192047)Spineology, Inc.2019-08-23
INFINITY Total Ankle System, INBONE Total Ankle System (K191393)Wrightmedicaltechnologyinc2019-08-22
HEALIX ADVANCE SP BIOCOMPOSITE Anchor (K191242)Medos International SARL2019-08-22
Triathlon Total Knee System-Additional Components (K190402)Stryker Orthopaedics (Aka Howmedica Osteonics Corp.)2019-08-22
NCB Polyaxial Locking Plate System (K192021)Zimmer GmbH2019-08-22
VSP Orthopedics System (K190044)3D Systems, Inc.2019-08-21
Exactech Equinoxe Humeral Augmented Trays (K191561)Exactech, Inc.2019-08-20
iNSitu Total Hip System (K191936)Thecken Companies, LLC2019-08-20
CrossRoads Screw System (K191342)Crossroads Extemity Systems, LLC2019-08-19
Zavation eZspand Interbody System (K191339)Zavation Medical Products, LLC2019-08-19
APTUS Foot System (K191636)Medartis AG2019-08-16
Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic 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 (K192018)Titan Spine, Inc.2019-08-16
TriMAX Implant System (K190722)Crossroads Extemity Systems, LLC2019-08-16
ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octane Straight, ChoiceSpine Intervertebral Fusion Device Octane Straight PC, ChoiceSpine VEO Laterial Access & Interbody Fusion System (K191621)Choice Spine, LLC2019-08-15
Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment (K190991)Howmedica Osteonics Corp. (Aka Stryker Orthopaedics)2019-08-15
AutoStrut (K191241)Orthospin2019-08-14
NuVaisve® Reline® Cervical System (K191553)Nu Vasive, Incorporated2019-08-14
BOSS Toe Fixation System (K190261)Arthrosurface, Inc.2019-08-14
PROSTEP™ TBI™ (Tailors Bunion Implant) System (K190970)Wrightmedicaltechnologyinc2019-08-13
Facilis™ Spinal System (K191494)Baui Biotech Co., Ltd.2019-08-12
EVOL® -SI Joint Fusion System (K190025)Cutting Edge Spine, LLC2019-08-12
ATEC Lateral Interbody System (K191311)Alphatec Spine, Inc.2019-08-12
Arsenal Plating System (K191009)Trilliant Surgical2019-08-12
Cervical Spinal Truss System-Stand Alone (CSTS-SA) (K190870)4Web, Inc.2019-08-12
Morpheus-C (K190371)Biogennix, LLC2019-08-09
ARx Spinal System (K191575)Life Spine, Inc.2019-08-08
iTotal Identity Cruciate Retaining Knee Replacement System (K190562)Conformis, Inc.2019-08-08
CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System (K190385)In2bones USA, LLC2019-08-08
Conformity Stem (K183312)United Orthopedic Corporation2019-08-08
Elevation Spine Saber-C System (K190885)Elevation Spine2019-08-07
BonAlive Granules (K191274)Bonalive Biomaterials, Ltd.2019-08-07
Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System (K191781)Zimmer GmbH2019-08-06
OrthoPediatrics PediFoot Deformity Corrections System (K190992)OrthoPediatrics Corp.2019-08-06
Normandy VBR System (K191423)Zavation Medical Products, LLC2019-08-06
Endoskeleton TCS Interbody Fusion Device (K191565)Titan Spine, Inc.2019-08-06
BiMobile Dual Mobility System - E-Dur Inserts (K190535)Waldemar Link GmbH & Co. KG2019-08-06
CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments (K191835)Globus Medical, Inc.2019-08-06
JAZZ PF (K191217)Implanet, S.A.2019-08-02
Elaris Pedicle Screw System (K183091)Spinewelding AG2019-08-02
LOQTEQ VA Calcaneus Plate 3.5 (K182818)Aap Implantate AG2019-08-01
SurgTech GENOLL Total Knee System (K191192)Surgtech, Inc.2019-08-01
Inion BioRestore (K191764)Inion OY2019-07-31
Addivation Medical Cervical Interbody System (K190291)Addivation Medical, LLC2019-07-30
Bone Screw Line Addition (K191289)Vilex IN Tennessee, Inc.2019-07-29
CoLink® Mini Plating System (K191535)In2bones USA, LLC2019-07-29
Arthrex Eclipse Shoulder Prosthesis System (K183194)Arthrex, Inc.2019-07-26
Medtronic Total Hip Arthroplasty System (K183129)Medtronic Advanced Energy2019-07-26
ActivOrtho Continuous Compression Screw System (K191817)Activortho, Inc.2019-07-26
JOURNEY II Unicompartmental Knee System (K191211)Smith & Nephew, Inc.2019-07-25
RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant (K190774)Medos International SARL2019-07-25
Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage (K183249)Stryker Spine2019-07-25
Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer (K183017)Osteoremedies, LLC2019-07-25
4CIS® Chiron Spinal Fixation System (K190471)Solco Biomedical Co., Ltd.2019-07-24
ProLift Expandable System (K190488)Life Spine, Inc.2019-07-23
Hammertoe Truss System (HTS) (K190926)4Web, Inc.2019-07-23
DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional (K190963)Synthes (USA) Products, LLC2019-07-23
Revival Modular Hip Stem (K191374)Corin U.S.A. Limited2019-07-22
Corin Optimized Position System Functional Hip Analysis (OPS FHA) (K190834)Corin USA2019-07-22
Mariner MIS Pedicle Screw System; SeaSpine Navigation System (K191648)SeaSpine Orthopedics Corporation2019-07-19
EUROPA Pedicle Screw System (K191757)MiRus, LLC2019-07-19
FAVO S-TLIF (K190680)Silony Medical GmbH2019-07-18
SPAR-K Instruments (for use with Gemini SL Total Knee System) (K191755)Waldemar Link GmbH & Co. KG2019-07-18
AOS ES Retrograde Femoral Nail (K191598)Advanced Orthopaedic Solutions, Inc.2019-07-18
MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System (K190895)Medos International SARL2019-07-18
Latitud Hip Replacement System (K183532)Meril Healthcare Pvt. , Ltd.2019-07-18
Xtreme-Loop (K191053)Xiros, Ltd.2019-07-17
Pegasus System (K191345)A.M. Surgical, Inc.2019-07-17
ORTHOLOC™ SPS Shoulder Plating System (K191711)Tornier, Inc.2019-07-17
EMPOWR Partial Knee (K191325)Encore Medical L.P.2019-07-16
MicroPort CoCr Femoral Heads (K190123)Microport Orthopedics, Inc.2019-07-15
UNiD Patient-matched PLIF cage (K182158)Medicrea International SA2019-07-15
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