510(k) Report

Devices descending from K950956

43 later devices reach Dura-Guard Dural Repair Patch, Dura-Guard Dura Substitute 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
+1K040888Duramatrix Collagen Dura Substitute MembraneCollagen Matrix, Inc.20043—
+1K031850Durasis Dural SubstituteCook Biotech, Inc.20032—
+1K991413Codman Ethisorb Dura PatchJohnson & Johnson Professionals, Inc.200014—
+1K973706Dura-Guard-Dural Repair PatchBio-Vascular, Inc.199733—
+2K212943SyntheCel Dura RepairSynthes (USA) Products, LLC20220—
+2K183513XenoSure Dura Biologic PatchLeMaitre Vascular, Inc.20190—
+2K172603Cerafix Dura SubstituteAcera Surgical, Inc.20170—
+2K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated201601
+2K153613Cerafix Dura SubstituteAcera Surgical, Inc.20167—
+2K131792Synthecel Dura Repair, Synthecel Dura OnlaySynthes, Inc.201315
+2K131015Biodesign Onlay Dural Graft or Biodesign Duraplasty GraftCook Biotech, Inc.20130—
+2K061487Duramatrix Collagen Dura Substitute Membrane - Onlay and SuturableCollagen Matrix, Inc.200612
+2K033395Codman Dural Graft Implant, Models 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476…Codman & Shurtleff, Inc.20042—
+2K982180Duragen Dural Graft MatrixIntegra Lifesciences Corp.1999301
+2K982282Dura-Guard - Dural Repair PatchBio-Vascular, Inc.1998131
+3K161278Cerafix Dura SubstituteAcera Surgical, Inc.20166—
+3K152481DURAFORM Dural Graft ImplantCodman & Shurtleff, Inc.201501
+3K061208Lifecell Dural Substitute MatrixLifecell Corp.20070—
+3K041000Durepair Dura Regeneration MatrixMedtronic Neurosurgery20047—
+3K041518Codman Duraform Dural Graft ImplantCodman & Shurtleff, Inc.20040—
+3K032693Duragen Plus Dural Graft MatrixIntegra Lifesciences Corp.200391
+3K021477Preclude MVP Dura SubstituteW. L. Gore & Associates, Inc.20023—
+4K223445ArtiFasciaNurami Medical, Ltd.20230—
+4K170300Restrata Wound MatrixAcera Surgical, Inc.201741
+4K161370Durepair Dura Regeneration MatrixMedtronic Neurosurgery201621
+4K150825Collagen Dural Regeneration MatrixCollagen Matrix, Inc.20150—
+4K122791Lyoplant OnlayAesculap, Inc.20130—
+4K092388Duragen Plus Dural Regeneration Matrix- Spinal Matrix, Model DP2013SM, Integra Spinal…Integra LifeSciences Corporation20100—
+4K072207Duragen XS Dural Regeneration MatrixIntegra Lifesciences Corp.200726
+4K063117Modification to Durepair Dura Regeneration MatrixMedtronic Neurosurgery20063—
+4K052211Durepair Dura Regeneration MatrixMedtronic Neurosurgery20055—
+4K043427Duragen II Dural Regeneration MatrixIntegra Lifesciences Corp.200532
+5K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+5K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+5K251191Collagen Dura Regeneration Membrane - RepairCollagen Matrix, Inc.20250—
+5K250420Helios Dura Regeneration MatrixHelios Biomedical, Inc.20250—
+5K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+5K193583Restrata®Acera Surgical, Inc.202011
+5K141608Collagen Dura MembraneCollagen Matrix, Inc.20150—
+5K120600Duragen Secure Dural Regneration MatrixIntegra Life Sciences20121—
+6K163456DuraGen Secure Dural Regeneration MatrixIntegra LifeSciences Corporation20170—