510(k) Report

Devices descending from P960025

1,714 later devices reach Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+4K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+4K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+4K212477EARP Interbody SystemNvision Biomedical Technologies, Inc.20221—
+4K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+4K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+4K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+4K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+4K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+4K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+4K212358Romero Cervical CageSpineup, Inc.20226—
+4K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+4K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+4K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+4K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+4K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+4K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+4K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+4K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+4K211740DualXAmplify Surgical, Inc.20211—
+4K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+4K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+4K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+4K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+4K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+4K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+4K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+4K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+4K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+4K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+4K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+4K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+4K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+4K210890GPS Cervical SpacersG Surgical, LLC20210—
+4K200919Idys ALIF 3DTiClariance20210—
+4K203444BEE HA CageNGMedical GmbH20211—
+4K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+4K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+4K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+4K200429BEE CagesNGMedical GmbH202111—
+4K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+4K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+4K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+4K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+4K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+4K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+4K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+4K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+4K200316UNiD IB3D ALIFMedicrea International SA20200—
+4K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+4K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+4K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+4K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+4K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+4K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+4K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+4K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+4K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+4K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+4K201087CORBEL SpacersGlobus Medical, Inc.202036—
+4K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+4K193106SpineFrontier Lumbar Interbody Fusion Device SystemSpinefrontier, Inc.20200—
+4K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+4K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+4K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+4K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+4K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+4K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+4K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+4K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+4K192993Scarlet AL-TSpineart20201—
+4K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+4K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+4K193174Keos Lumbar IBFDKeos20190—
+4K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+4K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+4K190721LongBow TiLife Spine, Inc.20190—
+4K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+4K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+4K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+4K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+4K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+4K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+4K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+4K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+4K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+4K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+4K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+4K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+4K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K190488ProLift Expandable SystemLife Spine, Inc.201916—
+4K183243Velofix TLIF CageU&I Corporation20190—
+4K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+4K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+4K191263Idys ALIF TiVacClariance, Sas20190—