510(k) Report

Devices descending from K993610

7 later devices reach Cytoplast Resorb, Models R-250, RP-250, RU-250, RPS-250, RPL-250 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132325Guidor Bioresorbable Matrix BarrierSunstar Americas, Inc.20130—
+1K080308Bio-Scaffold Bioscaff Alvelac Resobable ScaffoldBioscaffold International Pte, Ltd.20085—
+2K082419Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc.20092—
+2K090083Cytoflex Resorb, Model C03-0010 Through C03-090Unicare Biomedical, Inc.20091—
+3K253317Cytrans™ ElashieldGC America, Inc.20260—
+3K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+4K213260CMFlexTMDimension Inx Corp.20220—