Stryker Spine Receives FDA 510(k) Clearance for Serrato Pedicle Screw

By Julie A. Vetalice

Stryker Spine received FDA 510(k) clearance to market the Serrato™ Pedicle Screw, indicated for use in the non-cervical spine with the Xia® 3 system for additional fusion support.

Serrato screws feature serrated cutting flutes, a dual-thread pattern with numerous leads for rapid insertion and a buttress thread locking mechanism designed to minimize cross threading and splaying of the screw head.

Xia 3 comprises screws, blockers and hooks for fixation of rods and connectors to vertebrae or the spinal column to stabilize or correct deformity.

Source: Stryker Corp.

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory