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
+3K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+3K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+3K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+3K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+3K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+3K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc.20165—
+3K161379ELSA SpacersGlobus Medical, Inc.2016155—
+3K162264Cascadia Interbody SystemK2m, Inc.2016169—
+3K153665Prow Fusion-LNlt Spine, Ltd.20160—
+3K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+3K161129Pillar SA PTCOrthofix, Inc.201619—
+3K161405Valeo II Interbody Fusion Device SystemAmedica Corp.20164—
+3K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+3K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+3K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+3K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+3K160631Keos Lumbar IBFDKeos20161—
+3K153786Prow Fusion-VNlt Spine, Ltd.20166—
+3K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+3K153629ArcadiusXP C Spinal SystemAesculap Implant Systems, Inc.20167—
+3K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+3K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+3K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K160125Cascadia Interbody SystemK2m2016315—
+3K153413PASS LP Spinal SystemMedicrea International SA20160—
+3K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+3K160547Cascadia Interbody SystemK2m2016157—
+3K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+3K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+3K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+3K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+3K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+3K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+3K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+3K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+3K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+3K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+3K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+3K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+3K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+3K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+3K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+3K152304Tritanium PL CageStryker20154481
+3K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+3K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+3K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+3K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+3K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+3K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+3K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+3K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+3K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+3K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+3K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+3K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+3K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+3K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+3K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+3K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+3K142504SpineFrontier Lumbar Interbody Fusion Device SystemSpinefrontier, Inc.20154—
+3K150954Elite L Expandable Lumbar Fusion SystemInnova Spinal Technologies, LLC20156—
+3K142744Mecta-C TiPEEKMedacta International201512—
+3K142392Zavation Posterior LEIFZavation, LLC20150—
+3K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+3K142456GPS SpacersG Surgical, LLC20151—
+3K143360LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20159—
+3K143616AccuLIF TL and PL CageStryker Corporation20154694
+3K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+3K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+3K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+3K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+3K142271Zavation Z-Link LumbarZavation, LLC20149—
+3K142488SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria…Seaspine, Inc.2014116—
+3K142347Amedica Valeo II Interbody Fusion DeviceAmedica Corp.20145—
+3K141942Midline II TICentinel Spine, Inc.2014459—
+3K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+3K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+3K140319Coroent TI-C SystemNuvasive, Inc.2014590—
+3K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+3K133717Longbow Spacer SystemLife Spine20149—
+3K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+3K141005Z-Link CervicalZavation, LLC20144—
+3K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—
+3K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+3K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+3K131612Anyplus; Alif Peek Cages, Plif Peek Cages, T-Plif Peek Cages, Tlif Peek CagesGS Medical Co., Ltd.20148—
+3K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+3K132596Proposed OptimusCustom Spine, Inc.201451
+3K133614Aleutian Ibf SystemK2m, Inc.2014527—
+3K140003Coroent Small Interbody SystemNuvasive, Inc.2014453—
+3K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+3K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc.20145961
+3K140106S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014265—
+3K134038Camber Spine Diagon Oblique CageCamber Spine201428—
+3K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+3K133623C-PLUSPioneer Surgical Technology, Inc.2014598—
+3K133967Interbody Cage SystemAurora Spine2014227—
+3K133286Midline (TM)Centinel Spine, Inc.2014460—
+3K131276Lateral SynfixSynthes (USA) Products, LLC2014146—