510(k) Report

Devices descending from K081979

9 later devices reach Actifuse Bone Graft Substitute and E-Z-Fil and Shape Bone Graft Substitute through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130531UltrafuseBaxter Healthcare Corp20147—
+1K090850Actifuse Bone Graft Substitute, Actifuse Microgranules Bone Graft SubstituteApatech, Ltd.200901
+2K181225AltaporeBaxter Healthcare Corporation20186—
+3K192363AltaporeBaxter Healthcare Corporation20204—
+3K191513Altapore ShapeBaxter Healthcare Corporation20192—
+4K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+4K233259XerosynXerothera, Inc.20240—
+4K201464Altapore MISBaxter Healthcare Corporation20201—
+4K200640Altapore ShapeBaxter Healthcare Corporation20201—