510(k) Report

Devices descending from K010701

5 later devices reach Medtronic Sofamor Danek Biphasic Calcium Phosphate (BCP) Bone Void Filler through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081784Mastergraft PuttyMedtronic Sofamor Danek20081—
+1K040646Straumann GranulesThe Straumann Co.20042—
+2K201051Straumann BoneCeramicInstitut Straumann AG20200—
+2K140374Mastergraft PuttyMedtronic Sofamor Danek USA, Inc.20140—
+2K050170Fortoss Vital Bone Graft SubstituteBiocomposites, Ltd.20050—