510(k) Report

Devices descending from K051188

7 later devices reach Grafton DBM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130235Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II PuttyHans Biomed Corp.20140—
+1K091729Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp.20092—
+1K082463ProgenixMedtronic Sofamor Danek20080—
+1K081950Progenix PlusMedtronic Sofamor Danek, Inc.20081—
+1K080462Progenix DBM PuttyMedtronic Sofamor Danek20082—
+2K100883CarrigenEtex Corp.20100—
+2K102812Gamma-BSM; Beta-BSM; EquivaboneEtex Corporation20100—