510(k) Report

Devices descending from K040536

1,150 later devices reach Modification to Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K170235Lucent®Spinal Elements, Inc.2017107—
+6K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+6K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+6K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+6K172065Scarlet AC-TSpineart20172—
+6K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+6K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+6K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+6K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+6K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+6K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+6K161379ELSA SpacersGlobus Medical, Inc.2016155—
+6K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+6K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+6K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+6K160125Cascadia Interbody SystemK2m2016315—
+6K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+6K153400ProLift Expandable SystemLife Spine, Inc.201672—
+6K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+6K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+6K152651AccuLIF TL and PL CageStryker Corporation201530—
+6K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+6K152304Tritanium PL CageStryker20154481
+6K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+6K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+6K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+6K142487Chesapeake Stabilization SystemK2m, Inc.201571
+6K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+6K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+6K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+6K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+6K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+6K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+6K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+6K130853Idys (TM) CClariance20132—
+6K132505Acculif TL and PL CageCoalign Innovations, Inc.20136453
+6K131449Coalition SpacerGlobus Medical, Inc.2013235—
+6K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+6K130194Acculif XL CageCoalign Innovations, Inc.20131—
+6K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339—
+6K121852Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp201230—
+6K113252Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek2012306—
+6K112388Lanx Cervical SALanx, Inc.201126—
+6K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+6K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+6K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106—
+6K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+6K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+6K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+7K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+7K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+7K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+7K260660SABER-C SystemElevation Spine20261—
+7K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+7K242303MOD-COrthomod, LLC20260—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+7K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K253158VyBrate™ VBR SystemVy Spine, LLC20260—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+7K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+7K250560BEE HANGMedical GmbH20250—
+7K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+7K250540SABER-C SystemElevation Spine20252—
+7K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+7K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.20250—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+7K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+7K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+7K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+7K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+7K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+7K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+7K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+7K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+7K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+7K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+7K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+7K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402