FDA Grants 510(k) Approval to Stryker’s Spine Division

Stryker’s Spine Division secured 510(k) clearance from the FDA for its Serrato Pedicle Screw.

As part of the Xia 3 spinal system, the screw will be used to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of acute and chronic instabilities or deformities.

The device features serrated cutting flutes, a dual-thread pattern and a patented buttress thread locking mechanism to minimize cross threading and splaying of the screw head.