510(k) Report

Devices descending from K143683

3 later devices reach APEX-DL Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+1K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+2K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—