510(k) Report

Devices descending from K250182

2 later devices reach Innovasis Navigation Instruments through their predicates, nearest generation first.

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