510(k) Report

Devices descending from K083440

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132343Marigen Wound DressingKerecis Limited20135—
+1K131286Primatrix Dermal Repair ScaffoldTei Biosciences, Inc.20135—
+1K113866Porcine Dermal Xenografts Porcine Dermal MatrixBrennen Medical, LLC20120—
+1K100261Primatrix AG Antimicrobial Dermal Dermal Repair ScaffoldTei Biosciences, Inc.201063
+2K190528MariGen Wound ExtraKerecis Limited20193—
+2K172318Endoform Silver Dermal TemplateAroa Biosurgery20170—
+2K153364Kerecis SecureMeshKerecis Limited20160—
+2K153690PriMatrix Dermal Repair ScaffoldTei Biosciences, Inc.201644
+2K120605Permacol Surgical ImplantCovidien, LLC20124—
+3K250397Helios Dermal ScaffoldHelios Biomedical, Inc.20250—
+3K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited20250—
+3K241080Kerecis Parvus (50207)Kerecis Limited20241—
+3K213231Kerecis SiliconeKerecis Limited20221—
+3K201577MatriDermMedskin Solutions Dr. Suwelack AG20212—
+3K160181Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC20161—
+3K133011Diaphragmatic Hernia GraftCook Biotech, Inc.201411
+4K261224MatriDermMedskin Solutions Dr. Suwelack AG20260—
+4K250864MatriDerm pluS+ Bi-LayerMedskin Solutions Dr. Suwelack AG20250—
+4K171817Biodesign Diaphragmatic Hernia GraftCook Biotech Incorporated20180—
+4K172937Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC20170—