510(k) Report

Devices descending from K050553

381 later devices reach Novel VBR Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K230329F3D Interbody SystemCorelink, LLC20230—
+5K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+5K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+5K221172FOCUS Interbody SystemOc Medical Devices20220—
+5K213417Ghost Spacer SystemLife Spine, Inc.20220—
+5K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+5K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+5K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+5K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+5K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+5K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+5K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+5K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+5K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+5K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+5K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+5K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+5K201671A-Link ZAcuity Surgical Devices, LLC202125—
+5K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+5K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+5K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+5K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+5K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+5K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+5K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+5K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+5K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+5K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+5K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+5K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+5K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+5K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+5K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+5K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+5K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+5K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+5K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+5K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+5K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+5K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+5K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+5K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+5K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+5K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+6K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+6K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+6K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+6K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+6K242303MOD-COrthomod, LLC20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K250560BEE HANGMedical GmbH20250—
+6K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+6K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+6K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+6K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+6K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+6K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+6K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+6K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+6K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+6K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+6K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+6K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+6K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+6K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+6K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+6K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+6K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+6K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+6K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+6K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+6K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+6K223326Axiom PSR SystemRestor3D202301
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K223418DeGen Impulse AM™ SystemDegen Medical20236—
+6K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+6K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+6K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+6K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+6K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+6K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+6K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+6K222561AlignAcuity Surgical Devices, LLC202214—
+6K220610SOLO-LAurora Spine, Inc.20220—
+6K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+6K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+6K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+6K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+6K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+6K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+6K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+6K203003Pantheon IBFDPantheon Spinal20210—
+6K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+6K203444BEE HA CageNGMedical GmbH20211—
+6K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+6K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—