510(k) Report

Devices descending from K982282

13 later devices reach Dura-Guard - Dural Repair Patch through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132850Bovine Pericardium Suturable Dural Graft, Tutopatch DM Graft, Tutoplast Bovine…Rti Surgical, Inc.20140—
+1K113071Synthecel Dura Replacement DevicesSynthes201225
+1K061208Lifecell Dural Substitute MatrixLifecell Corp.20070—
+1K041000Durepair Dura Regeneration MatrixMedtronic Neurosurgery20047—
+2K212943SyntheCel Dura RepairSynthes (USA) Products, LLC20220—
+2K161370Durepair Dura Regeneration MatrixMedtronic Neurosurgery201621
+2K131792Synthecel Dura Repair, Synthecel Dura OnlaySynthes, Inc.201315
+2K122791Lyoplant OnlayAesculap, Inc.20130—
+2K063117Modification to Durepair Dura Regeneration MatrixMedtronic Neurosurgery20063—
+2K052211Durepair Dura Regeneration MatrixMedtronic Neurosurgery20055—
+3K251191Collagen Dura Regeneration Membrane - RepairCollagen Matrix, Inc.20250—
+3K250420Helios Dura Regeneration MatrixHelios Biomedical, Inc.20250—
+3K141608Collagen Dura MembraneCollagen Matrix, Inc.20150—