510(k) Report

Devices descending from K050378

2 later devices reach Synthes Mandible External Fixator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143285Mandible External Fixator - MR ConditionalSynthes USA Products, LLC20150—
+1K072764KLS Martin Xternal FixatorKLS Martin L.P.20070—