meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
37
Latest Decision
2016-03-23

Clearances · page 52 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K152631 MPO Total Knee Systems MR Labeling Microport Orthopedics, Inc. HRY Class II 2016-03-23
K160466 Response 5.5 Spine System OrthoPediatrics Corp. NKB Class II 2016-03-23
K160362 Z-Span Plate System Zavation, LLC KWQ Class II 2016-03-22
K153770 OS2(R)-VP Varisation Staple In2bones Sas JDR Class II 2016-03-21
K160208 NILE Alternative Fixation Spinal System K2m, Inc. OWI Class II 2016-03-18
K160484 Optetrak Advanced Patella Exactech, Inc. JWH Class II 2016-03-18
K153627 NuVasive® TLX Interbody System Nu Vasive, Incorporated MAX Class II 2016-03-17
K152686 CONQUEST FN Smith & Nephew JDO Class II 2016-03-17
K151268 SPINAUT-V, SPINAUT-S, SPINAUT-I Imedicom Co., Ltd. HRX Class II 2016-03-16
K153250 Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System Renovis Surgical Technologies OVE Class II 2016-03-16
K151665 SUSTAIN Additional Implants Globus Medical, Inc. MAX Class II 2016-03-16
K160409 AOS Anterolateral Proximal Humeral Plate Advanced Orthopaedic Solutions, Inc. KTW Class II 2016-03-15
K160114 Xspan Laminoplasty Fixation System X-Spine Systems, Inc. NQW Class II 2016-03-15
K152530 UCP Stem United Orthopedic Corporation LZO Class II 2016-03-14
K151271 BellaFuse Hans Biomed Corp. MQV Class II 2016-03-11
K152919 OMNI Skirted Heads Omni Life Science, Inc. LZO Class II 2016-03-10
K160069 Sonoma Fibula Repair System Sonoma Orthopedics Products, Inc. HSB Class II 2016-03-10
K152217 Exactech Vantage Total Ankle System Exactech, Inc. HSN Class II 2016-03-10
K153776 Optetrak One Logic Femoral Components Exactech, Inc. MBH Class II 2016-03-10
K160058 Biomet Variable Pitch Compression Screw System Biomet, Inc. HWC Class II 2016-03-09
K160002 Piccolo Composite(R) Distal Volar Radius Plate System CarboFix Orthopedics , Ltd. HRS Class II 2016-03-09
K152662 S-Wire Spinal Resources, Inc. HTY Class II 2016-03-09
K153326 Erisma-LP Spinal Fixation System Clariance, Sas NKB Class II 2016-03-08
K160085 Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System Zimmer GmbH KWS Class II 2016-03-08
K152262 Ventix Knotless Anchors Biomet Manufacturing Corp MBI Class II 2016-03-08
K160025 iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System Conformis, Inc. JWH Class II 2016-03-07
K153400 ProLift Expandable System Life Spine, Inc. MAX Class II 2016-03-07
K160418 PERIMETER Interbody Fusion Device Medtronic Sofamor Danek USA, Inc. MAX Class II 2016-03-07
K153438 PERIMETER C (Titanium) Spinal System Medtronic Sofamor Danek USA, Inc. ODP Class II 2016-03-02
K151708 RECON system - Compression Screws Normed Medizin-Technik GmbH HWC Class II 2016-03-02
K160020 Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System Captiva Spine MNH Class II 2016-03-02
K152681 iFuse Implant System(R) SI-BONE, Inc. OUR Class II 2016-03-01
K153575 Tyber Medical Trauma Screw Tyber Medical, LLC HWC Class II 2016-02-26
K151307 ICONACY(TM) I-Hip (TM) Iconacy Orthopedic Implants, LLC LZO Class II 2016-02-26
K160003 Sniper (R) Spine System Spine Wave, Inc. MNI Class II 2016-02-26
K151508 IRENE Locking Compression Plate System Tianjin Zhengtian Medical Instrument Co., Ltd. HRS Class II 2016-02-25
K151406 Cogent Lateral Interbody System Cogent Spine, LLC MAX Class II 2016-02-25
K153759 SIGN Compression Screw System Sign Fracture Care International HWC Class II 2016-02-25
K152539 SpineView X-Pac Expandable Lumbar Cage System Spine View, Inc. MAX Class II 2016-02-24
K151092 Arthrex Short Suture Anchors Arthrex, Inc. MBI Class II 2016-02-23
K153323 Palisade Pedicular Fixation System Spineology, Inc. NKB Class II 2016-02-23
K152557 Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters G21, S.R.L. NDN Class II 2016-02-23
K153548 VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM Visionsense, Ltd. HRX Class II 2016-02-22
K153215 SmartBase for Arthrex Glenoid IRIS Custom Orthopaedic Solutions, Inc. KWS Class II 2016-02-19
K153586 Arthrex iBalance TKA System Arthrex, Inc. MBH Class II 2016-02-19
K153216 Alpine Cemented Hip System Ortho Development Corporation JDI Class II 2016-02-18
K153395 OS2-C Compression Staple In2bones Sas JDR Class II 2016-02-18
K153442 CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE Systems Medtronic Sofamor Danek USA, Inc. NKB Class II 2016-02-18
K160291 Optimus ALIF System Amendia, Inc. OVD Class II 2016-02-18
K151580 D.N.E. External Fixation System Dne, LLC KTT Class II 2016-02-16
K153370 Caspian OCT/MESA Mini/DENALI Mini Spinal System K2m, Incorporated NKG Class II 2016-02-16
K153631 Zimmer Virage OCT Spinal Fixation System Zimmer Spine, Inc. NKG Class II 2016-02-16
K152187 MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws Merete Medical GmbH HWC Class II 2016-02-12
K153608 Vitoss BiModal Bone Graft Substitute Foam Strip Orthovita, Inc. MQV Class II 2016-02-12
K152781 Adena-Zina System Shanghai Sanyou Medical Co, Ltd. NKB Class II 2016-02-12
K152568 C-VBR Cardinal Spine, LLC PLR Class II 2016-02-11
K151553 Anterior Cervical Plate System Osteomed Implantes, Ltda KWQ Class II 2016-02-10
K153589 CD HORIZON Spinal System Medtronic Sofamor Danek USA, Inc. NKB Class II 2016-02-10
K153340 Epic Extremity Plate System Epic Extremity, LLC HRS Class II 2016-02-09
K143596 MINIARS SCREWS Overmed Srl. HWC Class II 2016-02-05
K152237 The Entasis Dual-Lead Sacroiliac Implant Corelink, LLC OUR Class II 2016-02-04
K153082 Rampart A Lumbar Interbody Fusion Device Spineology, Inc. MAX Class II 2016-02-04
K153398 Comprehensive SRS/Nexel Elbow Biomet Manufacturing Corp JDC Class II 2016-02-03
K153211 M-Fix Acromioclavicular Device Coracoid Solutions, Inc. HTN Class II 2016-02-02
K152324 YAHUA Spinal System Beijing Weigao Yahua Artificial Joint Development Co. , Ltd. MNI Class II 2016-02-01
K153204 In2Bones Kirschner wire In2bones Sas HTY Class II 2016-02-01
K153169 PASS OCT Patient Specific Rods Medicrea International NKG Class II 2016-01-29
K151735 TriMed Humeral Supracondylar Fixation System TriMed, Inc. HRS Class II 2016-01-29
K153428 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System Orthofix, Inc. NKB Class II 2016-01-29
K151939 COALITION Spacers Globus Medical, Inc. OVE Class II 2016-01-29
K153186 Adjustable Fixation Device Arthrocare Corp. MBI Class II 2016-01-28
K151716 Cable-Ready Cable Grip System: Cable-Ready Bone Plate System Zimmer, Inc. HRS Class II 2016-01-28
K153525 Seneka II Polyscrew Pedicle Fixation System Senecka Spine NKB Class II 2016-01-28
K153129 dynaMX Tabbed Staple Mx Orthopedics, Corp. JDR Class II 2016-01-28
K152512 Half Dome Posterior Lumbar Interbody System Astura Medical MAX Class II 2016-01-28
K151701 Tenodesis screw system Normed Medizin-Technik GmbH HWC Class II 2016-01-26
K153386 Perla Posterior Cervico-Thoracic Fixation system Spineart NKG Class II 2016-01-25
K153034 aap LOQTEQ VA Radius Set 2.5 Aap Implantate AG HRS Class II 2016-01-21
K153695 Biomet Spine Fusion System Biomet Spine, LLC MAX Class II 2016-01-21
K153381 Corin Metafix Hip Stem Corin U.S.A. Limited LZO Class II 2016-01-21
K153735 Release Laminoplasty Fixation System Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) NQW Class II 2016-01-21
K151726 AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, AVS ARIA PEEK Spacer Stryker Corporation MAX Class II 2016-01-20
K153664 M.U.S.T. Pedicle Screw System Medacta International NKB Class II 2016-01-19
K153333 Epic Extremity Cannulated Screw System Epic Extremity, LLC HWC Class II 2016-01-19
K152793 Unison-C Anterior Cervical Fixation System Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. OVE Class II 2016-01-19
K153373 CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device Medtronic Sofamor Danek ODP Class II 2016-01-19
K153669 MultiFIX S Ultra Knotless Fixation System Arthocare Corporation MBI Class II 2016-01-19
K152620 Spine Wave Gen II Expandable Interbody System Spine Wave, Inc. MAX Class II 2016-01-15
K151661 Renovo Life Hard Carbon Coated Drill Bit Renovo Life, LLC HTW Class I 2016-01-15
K151848 Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System Zimmer, Inc. JDQ Class II 2016-01-15
K153356 Spine Innovation Interbody System Spine Innovation, LLC MAX Class II 2016-01-14
K152475 FORZA PTC Spacer System Orthofix, Inc. MAX Class II 2016-01-14
K152966 Aequalis Fx2 Tornier S.A.S. PHX Class II 2016-01-14
K153338 Tiger Cannulated Screw System Trilliant Surgical, Ltd. HWC Class II 2016-01-14
K152972 Amendia Stand-Alone Cervical System Amendia, Inc. OVE Class II 2016-01-14
K151468 ARIX Wrist System Jeil Medical Corporation HRS Class II 2016-01-14
K153242 Frontier Medical Devices In-Line Orthopedic Cable Cerclage System Frontier Medical Devices, Inc. JDQ Class II 2016-01-13
K153635 SALVATION(R) External Fixation System Wrightmedicaltechnologyinc KTT Class II 2016-01-13
K153415 Reprocessed Stryker External Fixation Devices Stryker Sustainability Solutions KTT Class II 2016-01-13
K151312 VerteLP Interbody Fusion Device Vgi, LLC OVD Class II 2016-01-13

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