510(k) Report

Devices descending from K051089

4 later devices reach Gii Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+1K083567Gii Spinal Fixation System, Gii-TI-Poly Axial ScrewCo-Ligne AG20091—
+2K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+2K210306GII Spinal Fixation SystemColigne AG20210—