510(k) Report

Devices descending from K061407

27 later devices reach Primatrix Dermal Repair Scaffold through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090812Theraform Standard/SheetSewon Cellontech Co., Ltd.20095—
+1K083440Primatrix Dermal Repair ScaffoldTei Biosciences, Inc.200820—
+2K132343Marigen Wound DressingKerecis Limited20135—
+2K131286Primatrix Dermal Repair ScaffoldTei Biosciences, Inc.20135—
+2K112580Collagen Wound DressingDalim Tissen Co., Ltd.20124—
+2K113866Porcine Dermal Xenografts Porcine Dermal MatrixBrennen Medical, LLC20120—
+2K100261Primatrix AG Antimicrobial Dermal Dermal Repair ScaffoldTei Biosciences, Inc.201063
+3K190528MariGen Wound ExtraKerecis Limited20193—
+3K182725ApisSweetbio, Inc.20192—
+3K172318Endoform Silver Dermal TemplateAroa Biosurgery20170—
+3K153364Kerecis SecureMeshKerecis Limited20160—
+3K153690PriMatrix Dermal Repair ScaffoldTei Biosciences, Inc.201644
+3K140456Bio-Connekt Wound MatrixMLM Biologics, Inc.20140—
+3K120605Permacol Surgical ImplantCovidien, LLC20124—
+4K250397Helios Dermal ScaffoldHelios Biomedical, Inc.20250—
+4K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited20250—
+4K241080Kerecis Parvus (50207)Kerecis Limited20241—
+4K222143Apis (R), Veris (TM)Sweetbio, Inc.20230—
+4K213231Kerecis SiliconeKerecis Limited20221—
+4K211972Omeza Collagen MatrixOmeza, LLC20210—
+4K201577MatriDermMedskin Solutions Dr. Suwelack AG20212—
+4K160181Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC20161—
+4K133011Diaphragmatic Hernia GraftCook Biotech, Inc.201411
+5K261224MatriDermMedskin Solutions Dr. Suwelack AG20260—
+5K250864MatriDerm pluS+ Bi-LayerMedskin Solutions Dr. Suwelack AG20250—
+5K171817Biodesign Diaphragmatic Hernia GraftCook Biotech Incorporated20180—
+5K172937Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC20170—