510(k) Report

Devices descending from K071807

17 later devices reach Orthomend Soft Tissue Matrix through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083898SurgimendTei Biosciences, Inc.200993
+1K081272Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC200864
+2K171357SurgiMend PRS Meshed, Revize-XIntegra Lifesciences Corporation (Owner of Tei Biosciences)201702
+2K162965SurgiMend MP Collagen Matrix for Soft Tissue ReconstructionTei Biosciences, Inc.201701
+2K142887SIS Inguinal Hernia Repair GraftCook Biotech Incorprated20150—
+2K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+2K140501Xenmatrix Surgical GraftC. R. Bard20140—
+2K123128Seri Surgical ScaffoldAllergan20135—
+2K111436Porcine Surgical Mesh, Porcine Dermal MatrixBrennen Medical, LLC20111—
+3K172545SERI ContourSofregen Medical, Inc.20170—
+3K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+3K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+3K140533Galaflex MeshTepha, Inc.20143—
+3K113866Porcine Dermal Xenografts Porcine Dermal MatrixBrennen Medical, LLC20120—
+4K202425SurgiLattice scaffoldTepha, Inc.20210—
+4K162922GalaFORM 3DTepha, Inc.20170—
+4K161092GalaSHAPE 3DTepha, Inc.201611