meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
35
Latest Decision
2019-01-22

Clearances · page 37 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K182837 M.U.S.T. Mini Extension Medacta International S.A. NKG Class II 2019-01-22
K182970 EUROPA™ Pedicle Screw System MiRus, LLC NKB Class II 2019-01-22
K183553 Compress and Mini Compress Anti-Rotation Spindles Biomet, Inc. MBF Class II 2019-01-22
K182955 EZStart Interference Screw Conmed Corporation HWC Class II 2019-01-22
K182507 Tigon Medical Tissue Anchors Tigon Medical MBI Class II 2019-01-21
K182284 Tyber Medical PT Interbody Spacer Tyber Medical, LLC ODP Class II 2019-01-18
K181076 Responsive Arthroscopy Wedge Push-In Suture Anchors Responsive Arthroscopy, LLC MBI Class II 2019-01-18
K181190 Pinehurst Anterior Cervical Plate System Signature Orthopaedics Pty, Ltd. KWQ Class II 2019-01-17
K181338 Imboki Knee Instrument System Signature Orthopaedics Pty, Ltd. JWH Class II 2019-01-17
K181302 Bodycad Unicompartmental Knee System Bodycad Laboratories, Inc. HSX Class II 2019-01-17
K183060 CervAlign™ Anterior Cervical Plate System Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) KWQ Class II 2019-01-17
K181540 Estremo Citieffe Nailing System Citieffe S.R.L. HSB Class II 2019-01-16
K183510 T2 STRATOSPHERE Expandable Corpectomy System Medtronic Sofamor Danek USA, Inc. MQP Class II 2019-01-16
K183165 Pristine Scope Pristine Surgical HRX Class II 2019-01-16
K182489 4CIS® Pinehurst Anterior Cervical Plate system Solco Biomedical Co., Ltd. KWQ Class II 2019-01-16
K181096 Avenue P Cage System Zimmer Biomet Spine, Inc. OVD Class II 2019-01-15
K182478 Whistler Modular Pedicle Screw System Evolution Spine, LLC NKB Class II 2019-01-15
K182307 Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System Paragon 28, Inc. HSB Class II 2019-01-14
K182898 TenoTac Soft Tissue Fixation System Paragon 28, Inc. MBI Class II 2019-01-14
K182928 CD Horizon™ Spinal System Medtronic Sofamor Danek USA, Inc. NQP Class II 2019-01-11
K181377 PROSTEP MICA Screw System Wrightmedicaltechnologyinc HWC Class II 2019-01-11
K182500 Catalyst CSR Press-Fit Humeral Components Catalyst Orthoscience, Inc. KWT Class II 2019-01-11
K182212 Geo Staple System Gramercy Extremity Orthopedics, LLC JDR Class II 2019-01-11
K180228 II-Type Intervertebral Spacer Paonan Biotech Co., Ltd. MAX Class II 2019-01-11
K183011 Additive Orthopaedics Patient Specific 3D Locking Lattice Plates Additive Orthopaedics HRS Class II 2019-01-10
K181180 OSSIO™ Pin Product Family OSSIO , Ltd. HTY Class II 2019-01-10
K183071 VLIFT-s Vertebral Body Replacement System Stryker Spine PLR Class II 2019-01-10
K181118 Reliance Lumbar IBF System Reliance Medical Systems OVD Class II 2019-01-09
K181086 Cortical Fixation Systems Cousin Biotech Sas MBI Class II 2019-01-09
K181282 G3A 40 Bone Cement G21, S.R.L. LOD Class II 2019-01-09
K182439 TruShot with Y-Knot Shallow All-Suture Anchor Conmed Corporation MBI Class II 2019-01-08
K183470 Precision Ideal Eyes Arthroscopes Stryker HRX Class II 2019-01-07
K182114 FlareHawk Interbody Fusion System Integrity Implants, Inc. MAX Class II 2019-01-07
K182210 TiWAVE-L Porous Titanium Lumbar Cage Kalitec Medical, LLC MAX Class II 2019-01-07
K182621 CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver Conmed Corporation MBI Class II 2019-01-04
K180951 Responsive Arthroscopy Suture Anchor System Responsive Arthroscopy, LLC MBI Class II 2019-01-03
K183214 Raven Lumbar Plate System Choicespine, LP KWQ Class II 2019-01-03
K182736 OIC Suture Anchor System The Orthopaedic Implant Company MBI Class II 2018-12-28
K182461 LATITUDE EV Total Elbow Arthroplasty Tornier, Inc. JDB Class II 2018-12-27
K182099 Delta TT Pro Lima Corporate S.P.A. LPH Class II 2018-12-26
K181761 Zimmer Biomet Select Ceramic Heads Zimmer, Inc. LZO Class II 2018-12-26
K182783 DePuy Synthes Trauma Orthopedic Nail Implants DePuy Synthes HRS Class II 2018-12-26
K181120 2.8 mm/3.3 mm PopLok Suture Anchors Conmed Corporation MBI Class II 2018-12-21
K181752 Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) Stryker Corporation HRX Class II 2018-12-21
K180821 TruMatch Graft Cage - Long Bone Synthes (Usa), LLC HRS Class II 2018-12-21
K181555 Arthrex Fracture Adapter Hemi Shoulder Prosthesis Arthrex, Inc. KWS Class II 2018-12-21
K181589 Curiteva Lumbar Interbody Fusion System Curiteva, LLC MAX Class II 2018-12-20
K182670 FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute Prosidyan, Inc. MQV Class II 2018-12-20
K183239 CoreLink F3D™ Lateral System Corelink, LLC MAX Class II 2018-12-19
K182446 TruShot with Y-Knot All-Suture Anchor Conmed Corporation MBI Class II 2018-12-19
K180909 REVEL Spacers Globus Medical, Inc. ODP Class II 2018-12-18
K182878 Integra Salto Total Ankle System Ascension Orthopedics HSN Class II 2018-12-18
K182361 Arthrex Compression FT Screws Arthrex, Inc. HWC Class II 2018-12-18
K182989 AURORA™ Screw System MiRus, LLC HWC Class II 2018-12-18
K180772 Met One Czar Anterior Cervical Plate System Met One Technologies KWQ Class II 2018-12-17
K183162 Affixus Hip Fracture Nail Biomet, Inc. HSB Class II 2018-12-14
K181827 Affixus Natural Nail System Humeral Nail Zimmer GmbH HSB Class II 2018-12-14
K180768 Arthrex SwiveLock Anchors Arthrex, Inc. MAI Class II 2018-12-14
K181899 ROCCIA® PLIF Silony Medical GmbH MAX Class II 2018-12-13
K181824 CBT Screw Fixation System U&I Corporation NKB Class II 2018-12-13
K183145 IlluminOss Photodynamic Bone Stabilization System Illuminoss Medical, Inc. QAD Class II 2018-12-13
K182473 PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems K2m, Inc. KWQ Class II 2018-12-12
K182954 Salvo™ Spine System Spine Wave, Inc. NKB Class II 2018-12-12
K183383 ANAX™ OCT Spinal System U&I Corporation NKG Class II 2018-12-12
K182339 LEUCADIA AUTOLOK™ Pedicle Screw System Clearview Orthopedic Development, LLC NKB Class II 2018-12-12
K181625 Life Spine Resolute™ Threaded Cage System Life Spine, Inc. MAX Class II 2018-12-11
K183168 OpenLoc-L Spinal Fixation System L&K BIOMED Co., Ltd. NKB Class II 2018-12-11
K181744 BI-MENTUM dual mobility system Serf LZO Class II 2018-12-11
K182810 Distal Radius Plating System Miami Device Solutions, LLC HRS Class II 2018-12-10
K182584 Lucent® XP Spinal Elements, Inc. MAX Class II 2018-12-10
K181826 Glenoid Polyaxial Non-locking Screws Medacta International S.A. PHX Class II 2018-12-10
K183080 Mega Plus Spine System Bk Meditech, Co., Ltd. NKB Class II 2018-12-10
K180670 ICONN Campbell Interference Screw Iconn Orthopedics, LLC HWC Class II 2018-12-07
K182048 Avenir Complete Hip System Zimmer, Inc. LZO Class II 2018-12-07
K180754 C-Zero Pedicle Screw System, Freedom Pedicle Screw System Signature Orthopaedics Pty, Ltd. NKB Class II 2018-12-07
K182007 Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System Renovis Surgical Technologies OVD Class II 2018-12-07
K181357 PATRIOT® Lumbar Spacers, SUSTAIN® Spacers Globus Medical, Inc. MAX Class II 2018-12-06
K181231 DePuy Synthes T-PAL Spacer System Depuy Synthes Spine MAX Class II 2018-12-06
K181958 MagnetOs Putty Kuros Biosciences B.V MQV Class II 2018-12-06
K182125 EVOLUTION Stemmed CS Femur Microport Orthopedics, Inc. JWH Class II 2018-12-06
K181970 MectaLIF Posterior Extension Medacta International S.A. MAX Class II 2018-12-04
K182949 Healix™ Compression Screw System Nvision Biomedical Technologies, LLC HWC Class II 2018-12-04
K182418 V3 Segmental Plating System Atlas Spine, Inc. KWQ Class II 2018-11-29
K180665 SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System K2m, LLC MQP Class II 2018-11-28
K180498 NuVasive Reline Fenestrated Screws, High V+ Bone Cement Nu Vasive, Incorporated PML Class II 2018-11-28
K183010 Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks Smith & Nephew, Inc. JWH Class II 2018-11-28
K181693 SMS Femoral Stem Medacta International S.A. LZO Class II 2018-11-28
K182983 iFuse Implant System® SI-BONE, Inc. OUR Class II 2018-11-27
K182746 ATEC ALIF and LLIF Spacer System Alphatec Spine, Inc. MAX Class II 2018-11-27
K182346 TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws Exactech, Inc. MBH Class II 2018-11-26
K182470 Plateau Spacer System Life Spine MAX Class II 2018-11-26
K182684 HammerTechTM Fixation System Fusion Orthopedics, LLC HWC Class II 2018-11-23
K180573 Responsive Arthroscopy Interference Screw System Responsive Arthroscopy, LLC HWC Class II 2018-11-23
K180541 DePuy Synthes 2.0 mm Quick Insertion Screws Synthes USA Products, LLC HWC Class II 2018-11-21
K182352 SP-LINK™ System Medical Designs, LLC PEK Class II 2018-11-21
K180550 NuVasive Monolith Cervical Corpectomy System Nu Vasive, Incorporated PLR Class II 2018-11-20
K181806 ARIX Sternal System Jeil Medical Corporation HRS Class II 2018-11-20
K182535 R3 Anteverted Liners Smith & Nephew, Inc. MBL Class II 2018-11-19
K182201 Stratum™ Foot Plating System Nextremity Solutions, Inc. HRS Class II 2018-11-16
K181921 Solidity Vertebral Body Replacement Ulrich Medical USA MQP Class II 2018-11-16

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