510(k) Report

Devices descending from K973594

11 later devices reach Gore Resolut XT Regenerative Material through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090083Cytoflex Resorb, Model C03-0010 Through C03-090Unicare Biomedical, Inc.20091—
+1K033074Inion GTR Biodegradable Membrane SystemInion, Ltd.200481
+1K993610Cytoplast Resorb, Models R-250, RP-250, RU-250, RPS-250, RPL-250Osteogenics Biomedical, Inc.20007—
+1K990363Biomesh Biodegradable GTR BarrierSamyang Corp.19992—
+2K253317Cytrans™ ElashieldGC America, Inc.20260—
+2K132325Guidor Bioresorbable Matrix BarrierSunstar Americas, Inc.20130—
+2K131385Easy-GraftDegradable Solutions AG20130—
+2K080308Bio-Scaffold Bioscaff Alvelac Resobable ScaffoldBioscaffold International Pte, Ltd.20085—
+3K082419Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc.20092—
+4K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+5K213260CMFlexTMDimension Inx Corp.20220—