510(k) Report

Devices descending from K021477

3 later devices reach Preclude MVP Dura Substitute through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113071Synthecel Dura Replacement DevicesSynthes201225
+2K212943SyntheCel Dura RepairSynthes (USA) Products, LLC20220—
+2K131792Synthecel Dura Repair, Synthecel Dura OnlaySynthes, Inc.201315