510(k) Report

Devices descending from K984534

4 later devices reach Preclude Acuseal Dura Substitute through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021477Preclude MVP Dura SubstituteW. L. Gore & Associates, Inc.20023—
+2K113071Synthecel Dura Replacement DevicesSynthes201225
+3K212943SyntheCel Dura RepairSynthes (USA) Products, LLC20220—
+3K131792Synthecel Dura Repair, Synthecel Dura OnlaySynthes, Inc.201315