510(k) Report

Devices descending from K232468

3 later devices reach SC Medica FFX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252153FFX Facet Fixation SystemSc Medica20252—
+2K261209Ion-LSurGenTec, LLC20260—
+2K250679FFX Facet Fixation SystemSc Medica20250—