SpineGuard has filed for 510(k) FDA clearance to commercialize its Threaded PediGuard device for a new spinal application, the medical device company said Jan. 31.
The company's device is designed for accurate pedicle screw placement, but authorization from the FDA will allow the company to also commercialize its product for anterior approach instrumented spine surgery.
The filing represents SpineGuard's first expanded application for its Threaded PediGuard outside of pedicle screw placement, Stéphane Bette, cofounder and deputy CEO of SpineGuard, said.