510(k) Report

Devices descending from K112429

2 later devices reach Giza (R) Vertebral Body Replacement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+2K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—