X-spine Cortical Bone Screw System

X-spine Cortical Bone Screw System is an FDA 510(k)-cleared medical device (K180153) manufactured by X-Spine Systems, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 14, 2018. Regulation: 8.