510(k) Report

Devices descending from K112453

10 later devices reach Sterispineps Pedicle Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201648Sterispine™ PSSafe Orthopaedics202011
+1K171582NEO Pedicle Screw System™Neo Medical SA20170—
+1K170528Sterispine™ PSSafe Orthopaedics20172—
+1K151921Sterispine PSSafe Orthopaedics20153—
+1K151747Sterispine PSSafe Orthopaedics20153—
+1K150092STERISPINE PS Pedicle ScrewSafe Orthopaedics20154—
+1K140802Sterispine PSSafe Orthopaedics20144—
+1K130632Sterispine PS Pedicle ScrewSafe Orthopaedics20135—
+1K121299Sterispineps Pedicle Screw, Sterispineps RodSafe Orthopaedics20126—
+2K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—