510(k) Report

Devices descending from K192336

17 later devices reach Navigated Anterolateral Disc Prep Instruments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252742Navigated InstrumentsTyber Medical, LLC20251—
+1K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+1K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+1K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+2K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+2K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+2K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+2K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+2K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+3K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+3K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+3K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+3K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+3K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+3K230989Rod Registration FrameNu Vasive, Incorporated20230—
+4K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—