510(k) Report

Devices descending from K121989

1 later device reach Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure +… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241555Moldable Bone Void Filler and Moldable Bone Void Filler + CCCRti Surgical, Inc.20250—