510(k) Report

Devices descending from K953969

31 later devices reach Preclude Dura Substitute through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021477Preclude MVP Dura SubstituteW. L. Gore & Associates, Inc.20023—
+1K982180Duragen Dural Graft MatrixIntegra Lifesciences Corp.1999301
+2K113071Synthecel Dura Replacement DevicesSynthes201225
+2K040888Duramatrix Collagen Dura Substitute MembraneCollagen Matrix, Inc.20043—
+2K041000Durepair Dura Regeneration MatrixMedtronic Neurosurgery20047—
+2K033395Codman Dural Graft Implant, Models 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476…Codman & Shurtleff, Inc.20042—
+2K032693Duragen Plus Dural Graft MatrixIntegra Lifesciences Corp.200391
+2K031850Durasis Dural SubstituteCook Biotech, Inc.20032—
+3K212943SyntheCel Dura RepairSynthes (USA) Products, LLC20220—
+3K172603Cerafix Dura SubstituteAcera Surgical, Inc.20170—
+3K161370Durepair Dura Regeneration MatrixMedtronic Neurosurgery201621
+3K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated201601
+3K150825Collagen Dural Regeneration MatrixCollagen Matrix, Inc.20150—
+3K152481DURAFORM Dural Graft ImplantCodman & Shurtleff, Inc.201501
+3K131792Synthecel Dura Repair, Synthecel Dura OnlaySynthes, Inc.201315
+3K131015Biodesign Onlay Dural Graft or Biodesign Duraplasty GraftCook Biotech, Inc.20130—
+3K122791Lyoplant OnlayAesculap, Inc.20130—
+3K092388Duragen Plus Dural Regeneration Matrix- Spinal Matrix, Model DP2013SM, Integra Spinal…Integra LifeSciences Corporation20100—
+3K072207Duragen XS Dural Regeneration MatrixIntegra Lifesciences Corp.200726
+3K063117Modification to Durepair Dura Regeneration MatrixMedtronic Neurosurgery20063—
+3K061487Duramatrix Collagen Dura Substitute Membrane - Onlay and SuturableCollagen Matrix, Inc.200612
+3K052211Durepair Dura Regeneration MatrixMedtronic Neurosurgery20055—
+3K043427Duragen II Dural Regeneration MatrixIntegra Lifesciences Corp.200532
+3K041518Codman Duraform Dural Graft ImplantCodman & Shurtleff, Inc.20040—
+4K251191Collagen Dura Regeneration Membrane - RepairCollagen Matrix, Inc.20250—
+4K250420Helios Dura Regeneration MatrixHelios Biomedical, Inc.20250—
+4K141608Collagen Dura MembraneCollagen Matrix, Inc.20150—
+4K132850Bovine Pericardium Suturable Dural Graft, Tutopatch DM Graft, Tutoplast Bovine…Rti Surgical, Inc.20140—
+4K120600Duragen Secure Dural Regneration MatrixIntegra Life Sciences20121—
+4K061208Lifecell Dural Substitute MatrixLifecell Corp.20070—
+5K163456DuraGen Secure Dural Regeneration MatrixIntegra LifeSciences Corporation20170—