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
+2K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+2K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+2K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+2K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+2K233075“BioGend” Interbody Fusion System 001 CageBiogend Therapeutics Co., Ltd.20240—
+2K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+2K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+2K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+2K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+2K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+2K230219Eminent Spine 3D Lumbar Interbody Fusion SystemsEminent Spine, LLC20234—
+2K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+2K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+2K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+2K223776PEEK Spinal Infusion CageChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.20230—
+2K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+2K212701Eminent Spine 3D Cervical Interbody Fusion SystemEminent Spine20235—
+2K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+2K223251Hexanium PLIFSpinevision, S.A.S.20220—
+2K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+2K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+2K221844TDM Lumbar Interbody Fusion Cage SystemTdm Co., Ltd.20221—
+2K221687Pegasus-X Expandable PLIF SystemGS Medical Co., Ltd.20220—
+2K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+2K220902Navagio Lumbar CageKalitec Medical, LLC20220—
+2K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+2K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+2K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+2K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+2K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+2K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+2K212831MectaLIF ExtensionMedacta International S.A.20211—
+2K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+2K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+2K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+2K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+2K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+2K210359Hexanium TLIFSpinevision, S.A.S.20211—
+2K200551MectaLIF Transforaminal TiPEEKMedacta Inernational SA20214—
+2K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+2K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+2K201287Impulse Interbody Fusion SystemDegen Medical20208—
+2K201145X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20204—
+2K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+2K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+2K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+2K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+2K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+2K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+2K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+2K200552EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20200—
+2K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+2K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+2K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+2K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+2K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+2K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+2K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+2K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+2K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+2K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+2K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+2K191796Neo Cage SystemNeo Medical SA20190—
+2K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+2K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+2K190544XIHPOS™ ZFUZE™ Interbody Fusion SystemDifusion Technologies20190—
+2K1803473d CageFims Co., Ltd.20190—
+2K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+2K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+2K190398Republic Spine Restore Intervertebral Body Fusion SystemRepublic Spine, LLC20190—
+2K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+2K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+2K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+2K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+2K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+2K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+2K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+2K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+2K183092Kuros TLIF CageKuros Biosciences B.V20190—
+2K183049Reliance Lumbar IBF SystemReliance Medical Systems, LLC20197—
+2K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+2K181048Neo Cage System TMNeo Medical SA20191—
+2K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+2K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+2K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+2K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+2K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+2K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+2K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+2K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+2K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+2K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+2K173947Lumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC201801
+2K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+2K180695FBC 921 (Alif)Fbc Device Aps20180—
+2K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC201810—
+2K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+2K172480icotec Interbody Cage SystemIcotec AG20185—
+2K180687Reliance Lumber IBF SystemReliance Medical Systems20188—
+2K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—