SpineGuard Gets FDA’s 510(k) Clearance for Threaded PediGuard for Spine Surgery

SpineGuard has received the FDA’s 510(k) clearance for its Threaded PediGuard device for use in spinal surgery.

SpineGuard has developed a proprietary sensing technology that it calls dynamic surgical guidance (DSG), which streamlines the placement of implants in the skeleton.

The Threaded PediGuard clearance covers the device’s use in an anterior approach that will be particularly useful for deformity correction, said Stéphane Bette, SpineGuard’s co-founder and deputy CEO.