SpineGuard's PediGuard threaded instrument was cleared by the FDA for anterior approach spine procedures, the devicemaker said April 4.
The clearance will let the France-based company commercialize the threaded PediGuard in the U.S., according to a news release. The product is designed to assist with pedicle screw placement and is available in three diameters, according to SpineGuard's website.
SpineGuard was founded in 2009 and is known for its proprietary radiation-free, real-time sensing technology.