meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
32
Latest Decision
2017-12-13

Clearances · page 43 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K171058 Medacta Shoulder System: Threaded Glenoid Baseplate Medacta International S.A. PHX Class II 2017-12-13
K172052 Arthrex DynaNite Nitinol Staple Arthrex, Inc. JDR Class II 2017-12-13
K173484 CorticaLINK Spinal Fusion Platform Linkspine, Inc. NKB Class II 2017-12-11
K172405 SNIPER STAPLE SYSTEM, NON-STERILE Trilliant Surgical JDR Class II 2017-12-11
K172786 MDS Plating System Miami Device Solutions, LLC HRS Class II 2017-12-08
K173131 Rexious Spinal Fixation System Huvexel Co. , Ltd. NKB Class II 2017-12-08
K172756 Varian cage Medyssey USA, Inc. MAX Class II 2017-12-08
K173117 NuVasive® VersaTie™ System Nuvasive, Inc. OWI Class II 2017-12-07
K173267 MasterLoc Stem: Lateralized Plus Medacta International S.A. LZO Class II 2017-12-07
K173458 ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System Orthofix Srl HSB Class II 2017-12-07
K173153 Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System Nu Vasive, Incorporated MAX Class II 2017-12-06
K172425 OrthoPediatrics Wrist Fusion Plate Orthopediatrics, Inc. HRS Class II 2017-12-06
K173091 Boundary Anterior Lumbar Buttress Plate Nvision Biomedical Technologies, LLC KWQ Class II 2017-12-06
K173126 Arisstos™ Spinal System Ingenium Spine NKB Class II 2017-12-05
K173260 SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Vu e·POD System SeaSpine Orthopedics Corporation MAX Class II 2017-12-04
K172419 Velofix™ TLIF Cage U&I Corporation MAX Class II 2017-12-04
K173148 ACIF Coligne AG ODP Class II 2017-12-01
K172008 ARIX Humerus System Jeil Medical Corporation HRS Class II 2017-12-01
K173129 PRECICE System Nuvasive Specialized Orthopedics, Inc. HSB Class II 2017-12-01
K170553 Altus Spine Interbody Fusion System Altus Partners, LLC MAX Class II 2017-12-01
K172469 TiLock Modular Spinal System Genesys Spine NKB Class II 2017-11-30
K170868 FIXIT Threaded Anchor System S.B.M Sas Science For Bio Materials MAI Class II 2017-11-30
K171934 Birmingham Hip (BH) Dual Mobility Insert Smith & Nephew, Inc. LPH Class II 2017-11-30
K172936 Destiknee™ Total Knee System Meril Healthcare Pvt. , Ltd. JWH Class II 2017-11-30
K173522 Solanas® Posterior Stabilization System Alphatec Spine, Inc. NKB Class II 2017-11-30
K172767 Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid Zimmer, Inc. PHX Class II 2017-11-30
K173099 Fortis and Hana Anterior Cervical Plate System Huvexel Co. , Ltd. KWQ Class II 2017-11-30
K170690 M-Vizion Femoral Revision System Medacta International S.A. LZO Class II 2017-11-29
K170235 Lucent® Spinal Elements, Inc. MAX Class II 2017-11-29
K172019 Brisbane ALIF Device, Gladstone ALIF Device Signature Orthopaedics Pty, Ltd. OVD Class II 2017-11-29
K172020 Arlington PLIF/TLIF Cage Signature Orthopaedics Pty, Ltd. MAX Class II 2017-11-29
K172491 ICONN Square 2.5MM Suture Anchor Iconn Orthopedics, LLC MBI Class II 2017-11-29
K173121 Ankle Fusion Plating System In2bones Sas HRS Class II 2017-11-28
K170688 PIT’Stop® implant In2bones Sas HWC Class II 2017-11-28
K172300 CoLink View Plating System In2bones USA, LLC HRS Class II 2017-11-27
K173135 VariAx 2 System Stryker GmbH HWC Class II 2017-11-27
K171114 HEALIX ADVANCE KNOTLESS Anchor Medos International SARL MAI Class II 2017-11-27
K172497 NuVasive AttraX Scaffold Nu Vasive, Incorporated MQV Class II 2017-11-24
K172424 Velofix™ SA Cervical Cage U&I Corporation OVE Class II 2017-11-22
K172253 Altus Spine Cervical Interbody Fusion System Altus Partners, LLC ODP Class II 2017-11-21
K171073 Smith & Nephew, Inc. REDAPT Augments Smith & Nephew, Inc. LPH Class II 2017-11-21
K173030 Vertera Spine Cohere Cervical Interbody Fusion Device Nu Vasive, Incorporated ODP Class II 2017-11-21
K172650 Materialise PKA Guide System Materialise NV HSX Class II 2017-11-20
K172032 Modulift Vertebral Body Replacement (VBR) System Aesculap Implants Systems, Inc. PLR Class II 2017-11-20
K172921 Stryker Self-Punching ICONIX Stryker MBI Class II 2017-11-20
K173331 JOURNEY II XR Knee Instruments Smith & Nephew, Inc. JWH Class II 2017-11-16
K171543 Renovis Surgical Hip Replacement System Renovis Surgical Technologies OQG Class II 2017-11-16
K172634 Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics MBH Class II 2017-11-16
K172178 Minimally Invasive Bunion Plating System Trilliant Surgical, Ltd. HRS Class II 2017-11-16
K173051 Orthofix MJ-FLEX THE NEW METAIZEAU NAIL Orthofix Srl HTY Class II 2017-11-16
K172130 Resorbable Mesh Device SeaSpine Orthopedics Corporation MQV Class II 2017-11-16
K170206 Arthrex FiberTape Cerclage Arthrex, Inc. JDQ Class II 2017-11-15
K172157 DePuy Synthes Femoral Recon Nail System Synthes (USA) Products, LLC HSB Class II 2017-11-14
K173166 ANTHEM Fracture System Globus Medical, Inc. HRS Class II 2017-11-13
K163595 IMPIX 3D Print Cages Medicrea International SA MAX Class II 2017-11-13
K162315 FORTIFY Corpectomy Spacers Globus Medical, Inc. MQP Class II 2017-11-09
K170534 PROLIXUS TOTAL KNEE SYSTEM Otis Biotech Co., Ltd. JWH Class II 2017-11-09
K171911 Medline ReNewal Reprocessed Synthes External Fixation Systems Surgical Instrument Service and Savings, Inc. KTT Class II 2017-11-09
K170473 C2 femoral stem Lima Corporate S.P.A. LZO Class II 2017-11-08
K172620 SyndesMetrics Syndesmosis Repair System Mortise Medical, LLC HTN Class II 2017-11-08
K172083 Idys™ ALIF System Clariance, Sas OVD Class II 2017-11-08
K171473 Compressyn™ Staple Dallen Medical, Inc. JDR Class II 2017-11-07
K172446 SPIRA-C Open Matrix Cervical Interbody Camber Spine Technologies ODP Class II 2017-11-07
K172392 Lateral Spinal Truss System (LSTS) Interbody Fusion Device 4Web, Inc. MAX Class II 2017-11-07
K171004 Hintermann Series H2 Total Ankle System Dt Medtech, LLC HSN Class II 2017-11-07
K171365 Arthrex Knee Systems Arthrex, Inc. MBH Class II 2017-11-07
K172979 NuVasive® Growth Rod Conversion Set Nu Vasive, Incorporated PGM Class II 2017-11-06
K172260 Omni Foot Plating System Extremity Medical, LLC HRS Class II 2017-11-06
K172441 EPIC Extremity Fracture Plate System Epic Extremity, LLC HRS Class II 2017-11-06
K172054 Materialise Glenoid Positioning System Materialise NV KWS Class II 2017-11-03
K172328 SOVEREIGN™ Spinal System Medtronic Sofamor Danek USA, Inc. OVD Class II 2017-11-02
K172437 CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System Orthofix, Inc. ODP Class II 2017-11-02
K172674 Sapphire Cervical Implant System Sapphire Medical Group ODP Class II 2017-11-02
K170341 Medussa-PL Cage Medyssey USA, Inc. MAX Class II 2017-11-02
K171376 DynaNail TTC Fusion System MedShape, Inc. HSB Class II 2017-11-02
K172347 GMK Hinge, GMK Revision Medacta International S.A. KRO Class II 2017-11-01
K173175 Paramount Anterior Cervical Cage System Spine Wave, Inc. OVE Class II 2017-11-01
K170359 Trinity™ Dual Mobility System Corin U.S.A. Limited LZO Class II 2017-10-31
K173080 IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) Huvexel Co. , Ltd. MAX Class II 2017-10-31
K172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System Stryker Orthopaedics JWH Class II 2017-10-30
K170917 Bi-Ostetic Bioactive Glass Foam Berkeley Advanced Biomaterials MQV Class II 2017-10-30
K172351 AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert Encore Medical L.P. KWS Class II 2017-10-30
K172943 Flex-Thread Fibula Pin System Intrafuse, LLC HSB Class II 2017-10-30
K173104 Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly Total Joint Orthopedics, Inc. OQG Class II 2017-10-27
K173022 SeaSpine Ventura NanoMetalene System SeaSpine Orthopedics Corporation MAX Class II 2017-10-26
K172417 SILC® Fixation System Globus Medical, Inc. OWI Class II 2017-10-26
K172341 NuVasive® Modulus TLIF Interbody System Nu Vasive, Incorporated MAX Class II 2017-10-26
K172323 Omnia Medical VBR Omnia Medical, LLC MQP Class II 2017-10-26
K172617 Treace Medical Concepts (TMC) Compression Screw System Treace Medical Concepts, Inc. HWC Class II 2017-10-25
K172808 CosmoLock Pedicle Screw System Kalitec Direct, LLC NKB Class II 2017-10-25
K173095 VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with Fenestrations Medos International SARL NKB Class II 2017-10-25
K171914 Cortina™ Lumbar Cage System Neurostructures, Inc. MAX Class II 2017-10-25
K172334 Ortus™ Expandable Lumbar Interbody Fusion System Atlas Spine, Inc. MAX Class II 2017-10-25
K172251 UTS Stem United Orthopedic Corporation LPH Class II 2017-10-24
K172546 AnyPlus® Spinal Fixation System GS Medical Co., Ltd. NKB Class II 2017-10-23
K171293 G3™ Active Plate® Miniature System Genesis Fracture Care, Inc. HRS Class II 2017-10-23
K170056 IRENE Cannulated Screw System Tianjin Zhengtian Medical Instrument Co., Ltd. HWC Class II 2017-10-23
K172213 MECRON Cannulated Screw System Merete GmbH HWC Class II 2017-10-23
K172585 Liberty Anterior Cervical Plate Valorus Spine KWQ Class II 2017-10-23
K171938 KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set Medtronic PML Class II 2017-10-23

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