510(k) Report

Devices descending from K030736

1,101 later devices reach Verte-Stack Spinal System, Extra Small Sizes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+6K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+6K221172FOCUS Interbody SystemOc Medical Devices20220—
+6K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+6K222561AlignAcuity Surgical Devices, LLC202214—
+6K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+6K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+6K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+6K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+6K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+6K220610SOLO-LAurora Spine, Inc.20220—
+6K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+6K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+6K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+6K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+6K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+6K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+6K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+6K201793EDEN Peek CageJmt Co., Ltd.20210—
+6K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+6K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+6K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+6K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+6K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+6K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+6K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+6K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+6K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+6K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+6K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+6K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+6K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+6K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+6K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+6K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+6K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+6K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+6K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+6K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+6K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+6K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+6K200316UNiD IB3D ALIFMedicrea International SA20200—
+6K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+6K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+6K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+6K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+6K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+6K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+6K201087CORBEL SpacersGlobus Medical, Inc.202036—
+6K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+6K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+6K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+6K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+6K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+6K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+6K192897icotec Cervical CageIcotec AG20201—
+6K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+6K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+6K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+6K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+6K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+6K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+6K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+6K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+6K191778Omnia Medical VBROmnia Medical, LLC20195—
+6K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+6K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+6K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+6K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+6K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+6K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+6K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+6K182477Cervical SpacerAdditive Implants, LLC201915—
+6K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+6K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+6K182584Lucent® XPSpinal Elements, Inc.20183—
+6K182182YUKON OCT Spinal SystemK2m20185—
+6K181963ostaPek Interbody Fusion CagesColigne AG20181—
+6K181829Velofix TLIF CageU&I Corporation20181—
+6K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+6K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+6K181397DualXInnovasive, Inc.201815—
+6K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+6K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+6K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+6K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+6K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+6K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+6K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+6K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+6K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+6K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+6K171496Tritanium C Anterior Cervical CageStryker Spine2017129—