510(k) Report

Devices descending from K043048

10 later devices reach Grafton Plus DBM Paste through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060794Progenix DBM Putty and PasteMedtronic Sofamor Danek20069—
+2K132868CarricellEtex Corporation20153—
+2K080462Progenix DBM PuttyMedtronic Sofamor Danek20082—
+2K072265Progenix DMB PuttyMedtronic Sofamor Danek20084—
+3K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc.20172—
+3K082002Progenix PlusMedtronic Sofamor Danek20080—
+3K082463ProgenixMedtronic Sofamor Danek20080—
+3K081950Progenix PlusMedtronic Sofamor Danek, Inc.20081—
+4K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+4K242797OsteoFlo HydroFiberSurGenTec, LLC20241—