510(k) Report

Devices descending from K040482

1,621 later devices reach Ebi Esl Spine Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K173982FORTIFY Corpectomy SpacersGlobus Medical, Inc.20188—
+7K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+7K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+7K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+7K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+7K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+7K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+7K181203Juliet TiSpineart20181—
+7K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+7K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+7K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+7K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+7K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+7K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822—
+7K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+7K180376K2M Patient Specific RodsK2m, Inc.20182—
+7K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+7K172828Double Medical Cage SystemDouble Medical Technology, Inc.20181—
+7K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+7K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+7K172756Varian cageMedyssey USA, Inc.20171—
+7K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+7K173030Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated201722—
+7K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+7K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+7K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+7K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+7K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+7K171704CAPRI Corpectomy Cage SystemK2m201710—
+7K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+7K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+7K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+7K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+7K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+7K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+7K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+7K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+7K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+7K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+7K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+7K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+7K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+7K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+7K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+7K163543Biomet Fusion SystemZimmer Biomet Spine, Inc.2017124—
+7K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+7K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+7K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+7K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+7K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+7K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc.20165—
+7K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+7K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+7K161028K2M Growing Spine SystemK2m, Inc.20163—
+7K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+7K161369EVEREST Spinal SystemK2m, Incorporated20169—
+7K160631Keos Lumbar IBFDKeos20161—
+7K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+7K153517AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.201612—
+7K153436LATERAL Spine Truss System4Web, Inc.20165—
+7K153629ArcadiusXP C Spinal SystemAesculap Implant Systems, Inc.20167—
+7K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSpinevision S.A.201613—
+7K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+7K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+7K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+7K160418PERIMETER Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.20165—
+7K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+7K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+7K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+7K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+7K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+7K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+7K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+7K151216Everest Spinal SystemK2m, Inc.201511—
+7K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+7K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+7K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+7K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+7K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+7K150954Elite L Expandable Lumbar Fusion SystemInnova Spinal Technologies, LLC20156—
+7K140348Interbody CageEisertech, LLC2015235—
+7K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+7K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+7K143616AccuLIF TL and PL CageStryker Corporation20154694
+7K141187Impix Alif S/aMedicrea International SA201501
+7K141896Coroent SystemNu Vasive, Incorporated2014480—
+7K141942Midline II TICentinel Spine, Inc.2014459—
+7K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+7K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+7K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+7K133402K2M Modular HooksK2m, Inc.20140—
+7K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—
+7K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+7K132738Cogent Med-LifCogent Spine, LLC201413—
+7K133286Midline (TM)Centinel Spine, Inc.2014460—
+7K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+7K133216Crescent Spinal SystemMedtronic Sofamor Danek, Inc.201392—
+7K132700Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek, Inc.2013170—
+7K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc.20130—
+7K130461Stalif XCentinel Spine, Inc.201313—