510(k) Report

Devices descending from K062697

31 later devices reach Sis Hernia Repair Device, Surgisis Gold Hernia Repair Graft through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142887SIS Inguinal Hernia Repair GraftCook Biotech Incorprated20150—
+1K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+1K133306Sis Hernia GraftCook Biotech, Inc.20140—
+1K133011Diaphragmatic Hernia GraftCook Biotech, Inc.201411
+1K130547Endoform Reconstructive TemplateMesynthe, Ltd.20135—
+1K111695Hybrid GraftCook Biotech, Inc.20120—
+1K094061Kensey Nash Ecm Surgical PatchKensey Nash Corporation201010—
+1K073391Surgisis Biodesign Tissue GraftCook Biotech, Inc.20088—
+2K171817Biodesign Diaphragmatic Hernia GraftCook Biotech Incorporated20180—
+2K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+2K153633Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)2016121
+2K141053Ovine Tissue Matrix (Otm)TELA Bio, Inc.20142—
+2K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+2K132025Meso Bilayer Surgical MeshKensey Nash Corporation Dba Dsm Biomedical20136—
+2K103787Medeor MatrixKensey Nash Corp.20112—
+3K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc.20250—
+3K250598Endoform Reconstructive Template - PLGAAroa Biosurgery, Ltd.20250—
+3K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+3K163217GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20175—
+3K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+3K153632Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)20161—
+3K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+3K133169Meso Tendon MatrixKensey Nash Corporation Dba Dsm Biomedical20130—
+4K2326023DMatrix Surgical MeshPrintbio, Inc.20241—
+4K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+4K191773GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20190—
+4K181935Endoform Reconstructive Template - Non AbsorbableAroa Biosurgery, Ltd.20180—
+4K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+5K2433023DMatrix DynaFlex (DynaFlex)Printbio, Inc.20250—
+5K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—
+5K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20200—