510(k) Report

Devices descending from K081432

3 later devices reach Healos II Bone Graft Substitute through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+1K093390Healos Dental Bone Graft Substitute (Also Called Healos or Healos II) Model 6008, 6025Depuy Spine, Inc.20100—
+2K213260CMFlexTMDimension Inx Corp.20220—