510(k) Report

Devices descending from K170045

2 later devices reach Swedge™ Pedicle Screw Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+2K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—