510(k) Report

Devices descending from K130547

5 later devices reach Endoform Reconstructive Template through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153633Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)2016121
+1K141053Ovine Tissue Matrix (Otm)TELA Bio, Inc.20142—
+2K250598Endoform Reconstructive Template - PLGAAroa Biosurgery, Ltd.20250—
+2K153632Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)20161—
+3K181935Endoform Reconstructive Template - Non AbsorbableAroa Biosurgery, Ltd.20180—