510(k) Report

Devices descending from K180876

7 later devices reach DTRAX Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190201CORUS Spinal SystemProvidence Medical Technology, Inc.20196—
+2K212636CORUS Spinal System-XProvidence Medical Technology, Inc.20215—
+3K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+3K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+4K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+4K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+5K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—