510(k) Report

Devices descending from K161278

6 later devices reach Cerafix Dura Substitute through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223445ArtiFasciaNurami Medical, Ltd.20230—
+1K170300Restrata Wound MatrixAcera Surgical, Inc.201741
+2K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+2K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+2K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+2K193583Restrata®Acera Surgical, Inc.202011