510(k) Report

Devices descending from K191039

18 later devices reach Navigated T2 STRATOSPHERE Inserters and Navigated Templates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+2K252742Navigated InstrumentsTyber Medical, LLC20251—
+2K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+2K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+2K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+3K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+3K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+3K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+3K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+3K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+4K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+4K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K230989Rod Registration FrameNu Vasive, Incorporated20230—
+5K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—