510(k) Report

Devices descending from K032604

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210306GII Spinal Fixation SystemColigne AG20210—
+1K083567Gii Spinal Fixation System, Gii-TI-Poly Axial ScrewCo-Ligne AG20091—
+1K051089Gii Spinal Fixation SystemCo-Ligne AG20054—
+2K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+3K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—