510(k) Report

Devices descending from K113071

2 later devices reach Synthecel Dura Replacement Devices through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212943SyntheCel Dura RepairSynthes (USA) Products, LLC20220—
+1K131792Synthecel Dura Repair, Synthecel Dura OnlaySynthes, Inc.201315