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
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, 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—
+7K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, 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—
+7K243474MagnetOs MISKuros Biosciences B.V20250—
+7K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+7K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+7K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+7K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+7K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+7K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+7K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+7K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+7K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+7K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+7K240453ReBOSSISOrthorebirth Co., Ltd.202402
+7K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+7K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+7K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+7K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+7K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+7K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+7K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+7K230989Rod Registration FrameNu Vasive, Incorporated20230—
+7K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+7K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+7K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+7K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+7K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+7K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+7K212266FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation20217—
+7K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+7K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+7K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+7K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+7K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+7K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+7K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+7K182349Concorde LiftMedos International SARL20190—
+7K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+7K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+7K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+7K180376K2M Patient Specific RodsK2m, Inc.20182—
+7K173537Concorde Lift™Medos International SARL20181—
+7K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+7K161642CAVUX™ Cervical CageProvidence Medical Technology, Inc.20160—
+7K160856SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc.20165—
+7K161028K2M Growing Spine SystemK2m, Inc.20163—
+7K161369EVEREST Spinal SystemK2m, Incorporated20169—
+7K153695Biomet Spine Fusion SystemBiomet Spine, LLC201632
+7K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+7K151216Everest Spinal SystemK2m, Inc.201511—
+7K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+7K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+7K133402K2M Modular HooksK2m, Inc.20140—
+7K140007Abacus TM Spacer SystemSpine Wave, Inc.20144—
+7K132719Staxx Ibl SystemSpine Wave, Inc.20137—
+8K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+8K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+8K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+8K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+8K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+8K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+8K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+8K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+8K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+8K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+8K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+8K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+8K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+8K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+8K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+8K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+8K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+8K191575ARx Spinal SystemLife Spine, Inc.201910—
+8K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+8K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+8K181188EVEREST Spinal SystemK2m, Inc.20186—
+8K171321K2M Navigation InstrumentsK2m201711
+8K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+9K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+9K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+9K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+9K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+9K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+9K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+9K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—