meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
41
Latest Decision
2020-12-11

Clearances · page 27 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K203090 ELEOS Limb Salvage System featuring BIOGRIP Onkos Surgical JDI Class II 2020-12-11
K202684 GMK Total Knee System - TiNbN Coating Medacta International S.A. JWH Class II 2020-12-11
K200066 Posterior Fusion Plate, HA Posterior Fusion Plate Spinal Simplicity, LLC PEK Class II 2020-12-10
K201519 PROFEMUR® GLADIATOR® Cemented Classic Stem Microport Orthopedics, Inc. JDI Class II 2020-12-10
K192798 Zimmer Segmental System Zimmer, Inc. KRO Class II 2020-12-10
K200196 Taperloc® Complete Hip Stems Biomet Orthopedics LZO Class II 2020-12-08
K201253 Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation Smith & Nephew KTT Class II 2020-12-08
K200951 Accu-Joint Hemi Implant Accufix Surgical, Inc. KWD Class II 2020-12-08
K200789 LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal System L&K BIOMED Co., Ltd. NKB Class II 2020-12-04
K202034 aprevo Intervertebral Body Fusion Device Carlsmed, Inc. MAX Class II 2020-12-03
K203253 NuVasive ACP System Nu Vasive, Incorporated KWQ Class II 2020-12-03
K203367 LineSider™ Spinal System Integrity Implants, Inc. NKB Class II 2020-12-03
K203041 SMS Cementless Stem Medacta International S.A. LZO Class II 2020-12-02
K201072 Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 Ensemble Orthopedics, LLC KYI Class II 2020-12-02
K202659 Stryker Arthroscope Stryker HRX Class II 2020-12-01
K203268 Arthrex FiberTak Suture Anchor Arthrex, Inc. MBI Class II 2020-11-27
K203317 CarboClear X Pedicle Screw System CarboFix Orthopedics , Ltd. NKB Class II 2020-11-25
K202883 Sterile bone screw (PEEK ACL screw) Osteonic Co., Ltd. MBI Class II 2020-11-25
K202098 GLOBAL UNITE™ Platform Shoulder System Depuy Ireland UC PHX Class II 2020-11-25
K193377 TopLock Anchor System Fusion Orthopedics, LLC MBI Class II 2020-11-25
K202194 ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology Depuy Ireland UC MBH Class II 2020-11-25
K201193 SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene; SeaSpine Vu e•POD System; and SeaSpine Reef TH System, SeaSpine Vu a•POD Prime NanoMetalene IBD; and SeaSpine Shoreline ACS, SeaSpine Cambria System; SeaSpine Regatta Lateral System; and SeaSpine Meridian System, Shoreline Cervical Interbody RT System; and SeaSpine Beachside System SeaSpine Orthopedics Corporation MAX Class II 2020-11-25
K202959 PolyLock Plating System Fusion Orthopedics, LLC HRS Class II 2020-11-24
K202972 Anterior Cervical Plate System Nutech Spine and Biologics KWQ Class II 2020-11-24
K202475 PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G Heraeus Medical GmbH LOD Class II 2020-11-23
K203056 Invictus™ Spinal Fixation System Alphatec Spine, Inc. NKB Class II 2020-11-23
K202764 Ortho Solutions Plating System Ortho Solutions UK , Ltd. HRS Class II 2020-11-20
K203100 Arthrex Eclipse Titanium Humeral Head Arthrex, Inc. PKC Class II 2020-11-20
K203167 DePuy Corail AMT Hip Prosthesis DePuy Orthopaedics, Inc. LZO Class II 2020-11-19
K200171 SMR TT Augmented Glenoid System Lima Corporate S.P.A. PHX Class II 2020-11-19
K203138 FIREBIRD SI Fusion System Orthofix, Inc. OUR Class II 2020-11-18
K202535 Arthrex FastThread Interference Screw Arthrex, Inc. MAI Class II 2020-11-18
K200912 Freedom(R) - TiNbN Coated Knee Maxx Orthopedics, Inc. JWH Class II 2020-11-18
K202307 Activ Fuse Newclip Technics HRS Class II 2020-11-17
K202777 VeriFixx™ Small Bone Implant Armis Biopharma, Inc. HTY Class II 2020-11-17
K202444 Knotless TensionTight Button Implant System Arthrex, Inc. MBI Class II 2020-11-17
K201918 EVOS Large Fragment Plating System Smith & Nephew, Inc. HRS Class II 2020-11-16
K203149 M.U.S.T. MINI Posterior Cervical Screws System Medacta International S.A. NKG Class II 2020-11-16
K202762 Circular Fixation with Balanced Cable Transport Smith & Nephew, Inc. KTT Class II 2020-11-16
K202178 VersaLoop Anchor System T.A.G. Medical Products Corporation, Ltd. MBI Class II 2020-11-13
K203011 Monster Screw System Paragon 28, Inc. HWC Class II 2020-11-13
K202373 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HSN Class II 2020-11-13
K202355 Stryker Omega PEEK Knotless Anchor System Stryker MBI Class II 2020-11-13
K191433 AGILON® XO Shoulder Replacement System Implantcast GmbH HSD Class II 2020-11-12
K201568 Calvary Spine Pedicle Screw System Calvary Spine, LLC NKB Class II 2020-11-12
K193214 WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws Biomet, Inc. MBI Class II 2020-11-10
K200428 Multi-Drive Interference Screw System Nvision Biomedical Technologies, Inc. MBI Class II 2020-11-10
K193432 Vantage PSI System 3D Systems OYK Class II 2020-11-09
K202587 ATEC Lateral Interbody System Alphatec Spine, Inc. MAX Class II 2020-11-06
K202589 APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System Medartis AG HWC Class II 2020-11-06
K203076 Mecta-C Stand Alone Extension Medacta International S.A. OVE Class II 2020-11-06
K203154 KASILOF Cervical Plate System Kahtnu Surgical, Inc. KWQ Class II 2020-11-05
K202476 Salvo® Spine System Spine Wave, Inc. NKB Class II 2020-11-05
K202624 Z-Span Plate System Zavation Medical Products, LLC KWQ Class II 2020-11-04
K202581 Arthrex TightRope II Arthrex, Inc. MBI Class II 2020-11-04
K202198 FlareHawk Interbody Fusion System Integrity Implants, Inc. MAX Class II 2020-11-03
K202302 Atlas Spine Rebar (Ti) Spacer System Atlas Spine, Inc. ODP Class II 2020-10-30
K200316 UNiD IB3D ALIF Medicrea International SA MAX Class II 2020-10-30
K192989 Libertas E-XLPE Modular Liner Maxx Orthopedics, Inc. OQI Class II 2020-10-29
K202949 CONSTRUX Mini PEEK Spacer System Orthofix, Inc. ODP Class II 2020-10-29
K202496 ANTHEM Fracture System Globus Medical, Inc. HRS Class II 2020-10-29
K201692 NuVasive Modulus XLIF Interbody System Nu Vasive, Incorporated MAX Class II 2020-10-29
K202912 ARIX Ankle Distal Tibia System Jeil Medical Corporation HRS Class II 2020-10-29
K200332 EXPERT - Joint Fixation System GM Dos Reis Industria e Comercio Ltda. HTN Class II 2020-10-29
K202259 Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip Parcus Medical, LLC MBI Class II 2020-10-28
K200790 LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System L&K BIOMED Co., Ltd. NKB Class II 2020-10-28
K202935 Syntec Femoral Nail Extended System Syntec Scientific Corporation HSB Class II 2020-10-28
K201497 EVOS Cabling System Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) JDQ Class II 2020-10-28
K193038 Comprehensive Shoulder System Biomet Manufacturing Corp MBF Class II 2020-10-28
K202887 IlluminOss Bone Stabilization System Illuminoss Medical, Inc. QAD Class II 2020-10-27
K203099 Triathlon PKR System Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics HSX Class II 2020-10-27
K202065 DOLOMITE Anterior Cervical Stabilization System Astura Medical, LLC OVE Class II 2020-10-26
K200937 ACURA Stabilization System Indius Medical Technologies Pvt. , Ltd. NKB Class II 2020-10-26
K202489 AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System Advanced Orthopaedic Solutions, Inc. HRS Class II 2020-10-26
K202528 Cannulated Power Driver Attachment K2m, Inc. NKB Class II 2020-10-26
K202429 Mobio Total Knee System B-One Ortho, Corp. JWH Class II 2020-10-23
K202894 Wiltrom Spinal Fixation System Wiltrom Corporation Limited NKB Class II 2020-10-23
K202817 GEO Bone Screw System Gramercy Extremity Orthopedics, LLC HWC Class II 2020-10-22
K200507 PRO-DENSE LoVisc Bone Graft Substitute Wrightmedicaltechnologyinc MQV Class II 2020-10-21
K201427 Trivergent Spinal Fixation System Benvenue Medical, Inc. NKB Class II 2020-10-21
K202472 ACTIS Duofix Hip Prosthesis DePuy Orthopaedics, Inc. LPH Class II 2020-10-21
K202393 SpineJack Expansion Kit Stryker Corporation NDN Class II 2020-10-20
K200794 AccelFix Spinal Fixation System L&K BIOMED Co., Ltd. NKB Class II 2020-10-20
K193000 Hexanium® ACIF Spinevision, S.A.S. OVE Class II 2020-10-20
K202771 CD Horizon Spinal System Medtronic NKB Class II 2020-10-19
K200084 Zavation IBF System Zavation Medical Products, LLC MAX Class II 2020-10-19
K200045 MUTARS Cemented Femoral Stems Implantcast GmbH MEH Class II 2020-10-16
K201535 Cerament Bone Void Filler Bonesupport AB MQV Class II 2020-10-16
K201803 OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant OSSIO , Ltd. HTY Class II 2020-10-16
K202193 PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction S.B.M. Sas (Science & Bio Materials) MBI Class II 2020-10-16
K202016 Dall-Miles® Cable System Howmedica Osteonics Corp., Dba Stryker Orthopaedics JDQ Class II 2020-10-16
K202680 OsteoMed ExtremiFix Mini & Small Cannulated Screw System Osteomed, LLC HWC Class II 2020-10-15
K202327 Invictus™ OsseoScrew® System Alphatec Spine, Inc. NKB Class II 2020-10-15
K200718 Arthrosurface WristMotion Total Wrist Arthroplasty System Arthrosurface, Inc. JWJ Class II 2020-10-15
K201587 icotec Anterior Cervical Plate System Icotec AG KWQ Class II 2020-10-15
K202666 CONSTRUX Mini PTC Spacer System Orthofix, Inc. ODP Class II 2020-10-14
K202305 Zavation IBF System Zavation Medical Products, LLC MAX Class II 2020-10-13
K200596 G21 Cement, VADER® Pedicle System Icotec AG PML Class II 2020-10-13
K201962 Skeletal Dynamics Ulnar Shortening Plating System Skeletal Dynamics, Inc. HRS Class II 2020-10-13
K202740 Klassic Knee System Tibial Inserts, PS-Max Total Joint Orthopedics, Inc. JWH Class II 2020-10-09

17,115 clearances in the Orthopedic panel. Data: openFDA.