510(k) Report

Devices descending from K042295

1 later device reach Smartscrew II, Models 232010, 232012, 232014, 232016, 232018, 232020 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050388Refix Internal Fracture Fixation ScrewsXtremi-T, LLC20050—