510(k) Report

Devices descending from K073109

907 later devices reach Stalif TT Intervertebral Body Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+3K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+3K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+3K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+3K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+3K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+3K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+3K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+3K201087CORBEL SpacersGlobus Medical, Inc.202036—
+3K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+3K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+3K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+3K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+3K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+3K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+3K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+3K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+3K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+3K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+3K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+3K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+3K191134IB3D AlifMedicrea International SA20191—
+3K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+3K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+3K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+3K183407Triton CageMedyssey USA, Inc.20190—
+3K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+3K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K190680Favo S-TlifSilony Medical GmbH20190—
+3K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+3K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+3K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+3K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+3K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+3K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+3K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+3K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+3K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+3K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+3K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+3K181397DualXInnovasive, Inc.201815—
+3K181337Sypher Spacer SystemBiogennix, LLC20180—
+3K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+3K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemRenovis Surgical Technologies, Inc.201811—
+3K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+3K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+3K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+3K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+3K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+3K172009Cascadia Interbody SystemK2m, Inc.2017433
+3K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+3K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+3K172083Idys™ ALIF SystemClariance, Sas20177—
+3K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+3K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+3K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+3K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+3K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+3K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+3K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+3K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+3K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+3K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+3K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+3K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+3K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+3K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+3K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+3K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+3K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+3K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+3K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+3K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+3K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+3K153665Prow Fusion-LNlt Spine, Ltd.20160—
+3K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+3K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+3K153786Prow Fusion-VNlt Spine, Ltd.20166—
+3K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+3K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+3K160125Cascadia Interbody SystemK2m2016315—
+3K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+3K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+3K160291Optimus ALIF SystemAmendia, Inc.20160—
+3K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+3K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+3K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+3K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+3K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+3K152304Tritanium PL CageStryker20154481
+3K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+3K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+3K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+3K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+3K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+3K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+3K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+3K143616AccuLIF TL and PL CageStryker Corporation20154694
+3K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—