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Stryker receives FDA 510(k) clearance for pedicle screws

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Stryker’s spine division announced it has received FDA 510(k) clearance for the Serrato pedicle screw, which is to be used for the noncervical spine. The screws are part of the company’s Xia 3 Spinal System, according to a company press release.

The pedicle screws have serrated cutting flutes for quick insertion and a patented buttress-thread locking mechanism to reduce cross threading and splaying of the screw head. The Serrato screws can be used with different rod diameters and materials to fit the patient’s needs.

“Pedicle screws have been used for decades with very few changes to their design,” Bradley Paddock, president of Stryker’s spine division, said in the release. “The design innovations incorporated into Serrato reinforce our commitment to making industry-leading investments focused on providing the advanced spinal products and differentiated technologies that our surgeon customers have come to expect.”

Reference:

www.stryker.com