510(k) Report

Devices descending from K161370

2 later devices reach Durepair Dura Regeneration Matrix through their predicates, nearest generation first.

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