510(k) Report

Devices descending from K153613

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161278Cerafix Dura SubstituteAcera Surgical, Inc.20166—
+2K223445ArtiFasciaNurami Medical, Ltd.20230—
+2K170300Restrata Wound MatrixAcera Surgical, Inc.201741
+3K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+3K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+3K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+3K193583Restrata®Acera Surgical, Inc.202011