510(k) Report

Devices descending from K964342

11 later devices reach Cytoplast GBR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012144CytoflexUnicare Biomedical, Inc.20012—
+1K972278Cytoplast Regentex Titanium 250Osteogenics Co.199771
+2K201187Cytoplast Titanium-Reinforced PTFE MembranesOsteogenics Biomedical, Inc.20211—
+2K160493Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE…Salvin Dental Specialties20161—
+2K151344Cytoflex Tefguard Ti-Enforced MembraneUnicare Biomedical, Inc.20150—
+2K143327Neoss Ti Reinforced MembraneNeoss, Ltd.20152—
+2K091120Medpor Contain ImplantPorex Surgical, Inc.20101—
+3K221851Lumina-PTFE TitaniumCriteria Industria E Comercio DE Produtos Medicinais20230—
+3K222549OpenTexPurgo Biologics, Inc.20230—
+3K210797Bio-MEM Ti Reinforced MembraneB&Medi Co., Ltd.20220—
+3K102184Medpor Contain Can ImplantPorex Surgical, Inc.20110—