510(k) Report

Devices descending from P950002

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+7K212612Omnia Medical TiBrid-SCOmnia Medical, LLC20220—
+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—
+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—
+7K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+7K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+7K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+7K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+7K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+7K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201974—
+7K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+7K181014Tritanium PL CageStryker Spine2018137—
+7K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+7K180376K2M Patient Specific RodsK2m, Inc.20182—
+7K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+7K171425Concorde LiftMedos International SARL201782
+7K161642CAVUX™ Cervical CageProvidence Medical Technology, Inc.20160—
+7K160646XYcor® Expandable Spinal Spacer SystemAlphatec Spine, Inc.201641—
+7K161028K2M Growing Spine SystemK2m, Inc.20163—
+7K161369EVEREST Spinal SystemK2m, Incorporated20169—
+7K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+7K151216Everest Spinal SystemK2m, Inc.201511—
+7K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+7K133402K2M Modular HooksK2m, Inc.20140—
+8K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+8K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+8K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+8K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+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—
+8K231359RODIN™ Expandable Lumbar Cage SystemCtl Medical Corporation20230—
+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—
+8K182349Concorde LiftMedos International SARL20190—
+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—
+8K173537Concorde Lift™Medos International SARL20181—
+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—
+9K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+9K220025ARx® Spinal SystemLife Spine, Inc.20220—
+9K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+9K201006K2M Navigation InstrumentsK2m, Inc.20200—
+9K200070ARx Spinal SystemLife Spine, Inc.20209—
+10K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+10K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+10K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+10K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+10K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+10K210549ARx Spinal SystemLife Spine, Inc.20211—
+10K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+11K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—