510(k) Report

Devices descending from K991413

14 later devices reach Codman Ethisorb Dura Patch through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153613Cerafix Dura SubstituteAcera Surgical, Inc.20167—
+1K033395Codman Dural Graft Implant, Models 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476…Codman & Shurtleff, Inc.20042—
+1K031850Durasis Dural SubstituteCook Biotech, Inc.20032—
+2K161278Cerafix Dura SubstituteAcera Surgical, Inc.20166—
+2K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated201601
+2K152481DURAFORM Dural Graft ImplantCodman & Shurtleff, Inc.201501
+2K131015Biodesign Onlay Dural Graft or Biodesign Duraplasty GraftCook Biotech, Inc.20130—
+2K041518Codman Duraform Dural Graft ImplantCodman & Shurtleff, Inc.20040—
+3K223445ArtiFasciaNurami Medical, Ltd.20230—
+3K170300Restrata Wound MatrixAcera Surgical, Inc.201741
+4K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+4K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+4K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+4K193583Restrata®Acera Surgical, Inc.202011