510(k) Report

Devices descending from K153690

4 later devices reach PriMatrix Dermal Repair Scaffold through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250397Helios Dermal ScaffoldHelios Biomedical, Inc.20250—
+1K201577MatriDermMedskin Solutions Dr. Suwelack AG20212—
+2K261224MatriDermMedskin Solutions Dr. Suwelack AG20260—
+2K250864MatriDerm pluS+ Bi-LayerMedskin Solutions Dr. Suwelack AG20250—