510(k) Report

Devices descending from K072791

1,055 later devices reach Oracle Spacer, Opal Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+5K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+5K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+5K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+5K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+5K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+5K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+5K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+5K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+5K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+5K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+5K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+5K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+5K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+5K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+5K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+5K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+5K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+5K170235Lucent®Spinal Elements, Inc.2017107—
+5K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+5K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+5K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+5K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+5K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+5K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+5K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+5K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+5K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+5K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+5K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+5K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+5K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+5K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+5K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+5K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+5K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+5K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+5K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+5K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+5K152651AccuLIF TL and PL CageStryker Corporation201530—
+5K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+5K152304Tritanium PL CageStryker20154481
+5K142487Chesapeake Stabilization SystemK2m, Inc.201571
+5K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+5K141135Juliet LLSpineart2014146—
+5K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+5K141942Midline II TICentinel Spine, Inc.2014459—
+5K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+5K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+5K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+5K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+5K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+5K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+6K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+6K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+6K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+6K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K260660SABER-C SystemElevation Spine20261—
+6K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+6K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K253260ORIO-3D Cage SystemSpineCraft20260—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+6K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+6K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+6K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+6K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+6K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+6K252742Navigated InstrumentsTyber Medical, LLC20251—
+6K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+6K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+6K253331PressON Spinal Fixation SystemNexus Spine20250—
+6K250540SABER-C SystemElevation Spine20252—
+6K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+6K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+6K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+6K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+6K250556Porous Biologic ScaffoldVentris Medical20250—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+6K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+6K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+6K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+6K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—