510(k) Report

Devices descending from K150092

4 later devices reach STERISPINE PS Pedicle Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201648Sterispine™ PSSafe Orthopaedics202011
+1K151747Sterispine PSSafe Orthopaedics20153—
+2K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+2K170528Sterispine™ PSSafe Orthopaedics20172—