510(k) Report

Devices descending from P980048

1,422 later devices reach Bak/Cervical (Bak/C) Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+8K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+8K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+8K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+8K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+8K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+8K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+8K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+8K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+8K201006K2M Navigation InstrumentsK2m, Inc.20200—
+8K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+8K182349Concorde LiftMedos International SARL20190—
+8K173537Concorde Lift™Medos International SARL20181—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+9K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+9K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+9K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+9K230989Rod Registration FrameNu Vasive, Incorporated20230—
+10K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—