Certex Spinal Fixation System

Certex Spinal Fixation System is an FDA 510(k)-cleared medical device (K160428) 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 May 4, 2016. Regulation: 8.