510(k) Report

Devices descending from K223511

3 later devices reach Excella Navigation Instruments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+2K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+2K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501