510(k) Report

Devices descending from K062810

835 later devices reach Solitaire Anterior Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093629Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine20101431
+1K081501Solitaire Anterior Spinal SystemBiomet Spine20088341
+2K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+2K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+2K103369Vault Alif SystemSpinal USA201110—
+2K100043Coroent XLR Standalone SystemNuvasive, Inc.2010744—
+2K092211Chesapeake Spinal SystemK2m, Inc.2010450—
+3K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+3K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+3K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+3K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+3K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+3K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+3K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+3K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+3K151481Sahara Stabilization SystemK2m, Inc.20155—
+3K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+3K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+3K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+3K142487Chesapeake Stabilization SystemK2m, Inc.201571
+3K141798Sypher Spacer SystemBiogennix, LLC20151—
+3K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+3K132596Proposed OptimusCustom Spine, Inc.201451
+3K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+3K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+3K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+3K130445Vault Alif SystemSpinal USA20139—
+3K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+3K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+3K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+3K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+3K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+4K261408SABER-XA SystemElevation Spine20260—
+4K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K240715Idys® C ZP 3DTiClariance20240—
+4K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20230—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+4K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+4K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+4K212562Idys-C ZP 3DTiClariance, SA20211—
+4K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+4K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+4K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+4K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+4K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+4K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+4K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+4K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+4K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+4K201585Monterey AL Interbody SystemStryker Corporation202044
+4K201087CORBEL SpacersGlobus Medical, Inc.202036—
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+4K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+4K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+4K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+4K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+4K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+4K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+4K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+4K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+4K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+4K181337Sypher Spacer SystemBiogennix, LLC20180—
+4K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+4K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+4K180695FBC 921 (Alif)Fbc Device Aps20180—
+4K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+4K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemRenovis Surgical Technologies, Inc.201811—
+4K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+4K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+4K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+4K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+4K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+4K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+4K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+4K163595IMPIX 3D Print CagesMedicrea International SA2017282
+4K172083Idys™ ALIF SystemClariance, Sas20177—
+4K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+4K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+4K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+4K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+4K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+4K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+4K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+4K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+4K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+4K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+4K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+4K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+4K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+4K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+4K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+4K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+4K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+4K152622Alta ACDF SystemBiomet Spine20160—
+4K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—