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
+6K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+6K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+6K240442MagnetOs PuttyKuros Biosciences B.V20243—
+6K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+6K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+6K240458Synthetic Bone PuttyVentris Medical20242—
+6K240459Cerament Bone Void FillerBonesupport AB20240—
+6K232347MagnetOs GranulesKuros Biosciences B.V20242—
+6K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+6K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+6K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+6K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+6K232069Expandable Lumbar Fusion Cage (Type I,Type II)Shanghai Reach Medical Instrument Co, Ltd.20230—
+6K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+6K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+6K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+6K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+6K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+6K232315Catalyst Bone Void FillerOssdsign AB20237—
+6K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+6K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+6K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+6K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+6K223143SAGICO Spinal SystemSagico VA USA, LLC20230—
+6K231359RODIN™ Expandable Lumbar Cage SystemCtl Medical Corporation20230—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+6K213815SiJoin®T3Vgi Medical, Inc.20230—
+6K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+6K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+6K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+6K212612Omnia Medical TiBrid-SCOmnia Medical, LLC20220—
+6K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+6K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+6K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+6K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+6K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+6K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+6K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+6K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+6K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+6K211306LabyrinthZavation Medical Products, LLC20213—
+6K210728CONDUIT InstrumentsMedos International SARL20215—
+6K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+6K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+6K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+6K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+6K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+6K190885Elevation Spine Saber-C SystemElevation Spine201925—
+6K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201974—
+6K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+6K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+6K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+6K173508Everest Spinal SystemK2m20189—
+6K173030Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated201722—
+6K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+6K171519FLXfit™Expanding Orthopedics, Inc.2017711
+6K171425Concorde LiftMedos International SARL201782
+6K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+6K152011Lucent Intervertebral Body Fusion DeviceSpinal Elements, Inc.2016106—
+6K152539SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc.20166—
+6K151727Everest Spinal SystemK2m, Inc.201511—
+6K151483Biomet Spine Fusion SystemBiomet Spine, LLC20154—
+6K142360Everest Spinal SystemK2m, Inc.201522—
+6K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+6K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+6K141217Acculif TL and PL CageStryker Corporation20146423
+6K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+6K133784Vista-S Device, Associated InstrumentationZimmer Trabecular Metal Technology201429—
+6K141147Range Spinal SystemK2m, Inc.20141—
+6K133583Opticage Interbody Fusion Device, Model Series 9070Interventional Spine, Inc.20140—
+6K132559Monument SpacersGlobus Medical, Inc.2013166—
+6K133207Staxx (R) SystemSpine Wave, Inc.20131—
+6K131071Staxx Ibl SystemSpine Wave, Inc.20138—
+6K122801Providence Cervical CageProvidence Medical Technology, Inc.20131—
+6K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+6K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+7K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+7K263049SABER-C SystemElevation Spine20260—
+7K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+7K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+7K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—