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Orthopedic

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

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RecordFirmDate
Lumbar Spine Truss System Plating Solution (LSTS-PS) (K203065)4Web, Inc.2021-03-10
Hexanium TLIF (K210359)Spinevision, S.A.S.2021-03-10
PROPHECY Preoperative Navigation Alignment System (K202815)Wrightmedicaltechnologyinc2021-03-10
Versalock Periprosthetic Femur Plates System-GMReis (K201728)GM Dos Reis Industria e Comercio Ltda.2021-03-08
Apex 3D Total Ankle Replacement System (K210390)Paragon 28, Inc.2021-03-06
Republic Spine Dark Star Spinal System (K201420)Republic Spine, LLC2021-03-05
LOQTEQ Distal Lateral Femur Plate 4.5 System (K210043)Aap Implantate AG2021-03-03
FORZA Ti Spacer System (K203576)Orthofix, Inc.2021-03-03
Able Medical Devices Valkyrie Thoracic Fixation System (K202889)Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices2021-03-02
GMK Revision & Hinge Extension - TiNbN Coating (K210010)Medacta International S.A.2021-03-02
Shoulder System - TiNbN Coating (K203755)Medacta International S.A.2021-03-02
NuVasive Modulus ALIF System (K210271)Nu Vasive, Incorporated2021-03-01
LTJ Screws and Washer (K210268)Azurmeds, Inc.2021-02-26
T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral System, T2 Supracondylar Nail System (K203819)Stryker GmbH2021-02-26
iFuse-TORQ™ Implant System (K203247)SI-BONE, Inc.2021-02-25
CITRESPLINE and CITRELOCK ACL Implants (K210239)Acuitive Technologies, Inc.2021-02-24
ExtremiLOCK Lateral Ankle Fusion Plates (K203479)Osteomed2021-02-24
Parcus Titanium Interference Screws (K202662)Parcus Medical, LLC2021-02-22
Foot and Ankle System (K200062)Leith Medical, LLC2021-02-22
MectaLock Extension (K203493)Medacta International S.A.2021-02-22
A.L.P.S. Clavicle Plating System (K210192)Biomet, Inc.2021-02-19
DELTA XTEND Reverse Shoulder System (K210167)DePuy Orthopaedics, Inc.2021-02-19
Ultrasonic Osteotomy Surgical System (K201274)Smtp Technology Co., Ltd.2021-02-19
Comprehensive Vault Reconstruction System (K202232)Biomet Manufacturing Corp2021-02-19
Artemis Proximal Femoral Nail System (K201379)Glw, Inc.2021-02-19
Duo Expandable Interbody Fusion System (K210155)Spineology, Inc.2021-02-19
Born PT-LIF Cage HA (K202380)Spineworxx AG2021-02-19
4CIS SARA Spine System, 4CIS VERTU Spine System (K202498)Solco Biomedical Company India Private Limited2021-02-18
iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System (K210252)Conformis, Inc.2021-02-17
FITBONE(R) TAA (K203399)Wittenstein Intens GmbH2021-02-17
SpaceFlex Shoulder (K202338)G21, S.R.L.2021-02-17
Easytech® Anatomical Shoulder System (K201391)Fx Shoulder USA, Inc.2021-02-16
ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System (K210035)Aegis Spine2021-02-16
JuggerKnot Soft Anchor (K203740)Riverpoint Medical2021-02-12
Catalyst OrthoScience R1 Reverse Shoulder System (K202611)Catalyst Orthoscience, Inc.2021-02-12
MectaLIF Transforaminal TiPEEK (K200551)Medacta Inernational SA2021-02-12
TenoTac Soft Tissue Fixation System (K203385)Paragon 28, Inc.2021-02-11
EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing (K203557)Encore Medical L.P.2021-02-10
LINK Embrace Shoulder System - Reverse Configuration (K200368)Waldemar Link GmbH & Co. KG2021-02-05
LimaCorporate Kirschner Wire (K203475)Lima Corporate S.P.A.2021-02-05
The Citrefix Knotless Suture Anchor (K203334)Acuitive Technologies, Inc.2021-02-05
ELEOS™ Limb Salvage System (K203588)Onkos Surgical2021-02-05
SYMPHONY™ OCT System (K203319)Medos International SARL2021-02-05
Prase PEEK Anterior Cervical Interbody Spacer (K202872)Gbs Commonwealth Co., Ltd.2021-02-04
EcoFit® Hip System (K203420)Implantcast GmbH2021-02-03
Balex bone Expander System (K202027)Taeyeon Medical Co., Ltd.2021-02-03
UNiTi ACDF Implant System (K200301)Pressio, Inc.2021-02-03
Arthrex Pilon Fusion System (K203294)Arthrex, Inc.2021-02-03
Smart SPACE Shoulder System (K202151)Techmah Medical, LLC2021-02-03
BioPoly Great Toe Hemiarthroplasty Implant (K203634)BioPoly, LLC2021-02-02
INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers (K203278)Globus Medical, Inc.2021-02-02
HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture (K203794)Medos International SARL2021-02-01
Hoffmann LRF System (K203568)Stryker GmbH2021-02-01
XYPAN Expandable Lumbar Cage System (K203531)Aegis Spine, Inc.2021-01-29
Prase-AP Anterior Cervical Plate System (K202878)Gbs Commonwealth Co., Ltd.2021-01-29
BEE Cages (K200429)NGMedical GmbH2021-01-29
PediFlex Flexible Nail System (K201838)OrthoPediatrics Corp.2021-01-29
Ti3Z Cervical Interbody System (K202398)Zavation Medical Products, LLC2021-01-29
Vitality® Spinal Fixation System (K203507)Zimmer Biomet Spine, Inc.2021-01-28
Biomet Microfixation RibFix Advantage System (K203474)Biomet Micofixation2021-01-28
EVOS Large Fragment Plating System (K203405)Smith & Nephew, Inc.2021-01-27
Altus Spine HA Pedicle Screw System (K200922)Altus Partners, LLC2021-01-26
M.U.S.T. Pedicle Screw Extension and Long Tab Implants (K203482)Medacta International S.A.2021-01-26
VERTACONNECT TLIF Cage (K203327)Signus Medizintechnik2021-01-25
Flex-ThreadTM Distal Fibula Intramedullary Nail System (K202858)Conventus Orthopaedics, LLC2021-01-22
Advanced Research Medical Trident SI Screw System (K203373)Advanced Research Medical, LLC2021-01-22
CREO Stabilization System, Navigation Instruments, ExcelsiusGPS (K203153)Globus Medical, Inc.2021-01-19
Biocore9 Femoral Head Resurfacing Component (K201219)Biocore9, LLC2021-01-19
Sequel External Fixation Device (K202833)Sequel Medical, Inc.2021-01-19
SnugFit All-Suture Anchor (K203485)Medacta International S.A.2021-01-19
EBERLE Shaver System C3 and Accessories (K193608)Eberle GmbH & Co. KG2021-01-15
CD HORIZON™ Spinal System (K203678)Medtronic Sofamor Danek USA, Inc.2021-01-15
CarboClear Lumbar Cage System (K203683)Carbofix Orthpedics , Ltd.2021-01-15
Dynanail Mini Hybrid (K203381)MedShape, Inc.2021-01-15
PERLA® TL posterior osteosynthesis system (K203506)Spineart2021-01-15
Ali Interbody Fusion System (K203308)Raed M. Ali, M.D., Inc.2021-01-15
Maven Patient-Specific Instrumentation (K202019)Paragon 28, Inc.2021-01-14
M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System (K203671)Medacta International S.A.2021-01-13
Inion CompressOn Screw (K203105)Inion OY2021-01-13
NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System (K203129)Precision Spine, Inc.2021-01-12
NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Hyperlordotic System, Brigade Standalone System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, Modulus ALIF System (K203201)Nu Vasive, Incorporated2021-01-12
C Scope Visualization System (K203526)Cit Ortho2021-01-12
GetSet Surgical GoPLF! Posterior Lateral Fusion System (K202505)Getset Surgical, SA2021-01-11
M-Vizion Femoral Revision System Extension (K201471)Medacta International S.A.2021-01-11
Button Loop (K202291)Yunyi (Beijing) Medical Device Co., Ltd.2021-01-08
ACS LD Uni FB Knee System (K203341)Implantcast GmbH2021-01-08
ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System (K201259)Wrightmedicaltechnologyinc2021-01-08
ZSFab Cervical Interbody System (K202488)Zsfab, Inc.2021-01-07
OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design (K203465)OSSIO , Ltd.2021-01-06
AutoStrut G2 (K202810)Orthospin, Ltd.2021-01-06
SIRION Lateral Lumbar Interbody Fusion (K202495)Astura Medical, LLC2021-01-06
Fixone Biocomposite Interference Screw (K193497)Aju Pharm Co., Ltd.2021-01-05
Bfix Orthopedic External Fixator Systems (K200491)Aike (Shanghai) Medical Instrument Co., Ltd.2021-01-05
Arthrex Low Profile Screws (K203239)Arthrex, Inc.2020-12-30
Baby Gorilla/Gorilla Plating System (K203511)Paragon 28, Inc.2020-12-29
Attune Revision Sleeve LPS Femoral Adaptors (K202248)Depuy Ireland UC2020-12-28
Uni-FuZe-P Bone Putty (K201781)Zavation Medical Products, LLC2020-12-28
Smart SPACE Shoulder System (K202454)Techmah Medical, LLC2020-12-28
Quadra-P (K202730)Medacta International S.A.2020-12-28
Tailored-C Cervical Interbody Fusion System (K200458)Bespoke Technologies2020-12-28
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