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
+5K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+5K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+5K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+5K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+5K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+5K181014Tritanium PL CageStryker Spine2018137—
+5K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+5K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+5K173080IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)Huvexel Co., Ltd.20172—
+5K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+5K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+5K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+5K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+5K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+5K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201782—
+5K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+5K163491NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2017289—
+5K162921Navigated Instrument SystemOrthofix, Inc.20175—
+5K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+5K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+5K162587Roccia® AcifSilony Medical GmbH20171—
+5K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+5K160076XCage™ Interbody Fusion SystemOuroboros Medical, Inc.2016141
+5K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+5K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+5K160646XYcor® Expandable Spinal Spacer SystemAlphatec Spine, Inc.201641—
+5K152622Alta ACDF SystemBiomet Spine20160—
+5K160715AccuLIF TL and PL CageStryker Corporation20160—
+5K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+5K153400ProLift Expandable SystemLife Spine, Inc.201672—
+5K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+5K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+5K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+5K142634Biomet Spine Fusion SystemBiomet Spine, LLC20155—
+5K142498MAGNIFY and MAGNIFY-S SpacersGlobus Medical, Inc.2015175—
+5K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+5K140716Opticage Expandable Interbody Fusion DeviceInterventional Spine, Inc.20140—
+5K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+5K140411Altera SpacerGlobus Medical, Inc.201419122
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K133418Integra Expandable Interverebral Body Fusion Device (Ibd) SystemSeaspine, Inc.20145—
+5K133514Xcage Interbody Fusion SystemOuroboros Medical201415—
+5K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+5K132757Everest Spinal SystemK2m, Inc.201341—
+5K132361Everest Spinal SystemK2m, Inc.201334—
+5K131723Coroent Single Tab SystemNuvasive, Inc.2013466—
+5K132505Acculif TL and PL CageCoalign Innovations, Inc.20136453
+5K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+5K124012Infill Oblique Tlif DevicePinnacle Spine Group, LLC20136—
+5K123461Staxx (R) IB SystemSpine Wave, Inc.2013251
+5K130194Acculif XL CageCoalign Innovations, Inc.20131—
+5K123993Solus Anterior Lumbar Interbody Fusion (Alif) SystemAlphatec Spine, Inc.20130—
+5K123231Caliber SpacersGlobus Medical, Inc.2013657—
+5K121320C7 Anterior Cervical Intervertebral Fusion CageMedyssey Co, Ltd.20122—
+5K113285LDR Spine Usa Avenue L Interbody FusionLdr Spine USA, Inc.2012199—
+5K121733Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC201221—
+5K120101Independence SpacerGlobus Medical, Inc.2012224—
+5K113447Rise SpacerGlobus Medical, Inc.2012691—
+5K113527Opticage Interbody Fusion DeviceInterventional Spine, Inc.2012103—
+5K113465Acculif TL CageCoalign Innovations, Inc.2011718—
+5K112095Acculif TL-Peek Ibf CageCoalign Innovations, Inc.2011319—
+5K111983Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-XxxxxxZimmer Trabecular Metal Technology201131—
+5K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K260660SABER-C SystemElevation Spine20261—
+6K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+6K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+6K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+6K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+6K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+6K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+6K250540SABER-C SystemElevation Spine20252—
+6K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+6K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+6K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+6K250556Porous Biologic ScaffoldVentris Medical20250—
+6K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+6K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+6K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+6K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+6K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+6K241895Cannulated PsiFGuardSpineguard20240—
+6K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+6K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+6K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+6K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+6K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+6K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—