510(k) Report

Devices descending from K212197

3 later devices reach WasherCap Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250238WasherCap™ Fixation SystemAbanza Tecnomed S.L20250—
+1K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+2K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—