510(k) Report

Devices descending from P950002

1,681 later devices reach Bak Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+6K212930LumiVy Lumbar IBF SystemVy Spine, LLC20226—
+6K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+6K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+6K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+6K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+6K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+6K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+6K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+6K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+6K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+6K211306LabyrinthZavation Medical Products, LLC20213—
+6K210728CONDUIT InstrumentsMedos International SARL20215—
+6K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+6K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+6K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+6K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+6K202637F3D Corpectomy SystemCorelink, LLC20201—
+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—
+6K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+6K193258ProLift Expandable SystemLife Spine, Inc.20203—
+6K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+6K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+6K190721LongBow TiLife Spine, Inc.20190—
+6K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+6K190885Elevation Spine Saber-C SystemElevation Spine201925—
+6K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+6K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+6K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+6K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+6K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+6K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+6K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+6K173283Reliance Lumbar IBF SystemReliance Medical Systems, LLC20189—
+6K173508Everest Spinal SystemK2m20189—
+6K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+6K173030Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated201722—
+6K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+6K171519FLXfit™Expanding Orthopedics, Inc.2017711
+6K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+6K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201782—
+6K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+6K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+6K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+6K162262Tritanium® PL CageStryker2016132—
+6K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201683—
+6K160955Tritanium® PL CageStryker2016178—
+6K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+6K160715AccuLIF TL and PL CageStryker Corporation20160—
+6K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+6K151727Everest Spinal SystemK2m, Inc.201511—
+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—
+6K122801Providence Cervical CageProvidence Medical Technology, Inc.20131—
+6K123913Latis SpacerGlobus Medical, Inc.201388—
+6K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+7K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+7K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+7K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+7K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+7K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+7K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+7K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+7K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+7K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+7K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+7K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+7K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+7K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+7K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+7K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+7K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+7K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+7K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+7K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+7K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+7K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+7K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+7K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—