510(k) Report

Devices descending from K063117

3 later devices reach Modification to Durepair Dura Regeneration Matrix through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161370Durepair Dura Regeneration MatrixMedtronic Neurosurgery201621
+2K251191Collagen Dura Regeneration Membrane - RepairCollagen Matrix, Inc.20250—
+2K250420Helios Dura Regeneration MatrixHelios Biomedical, Inc.20250—