CERTEX OCT SPINAL IMPLANT SYSTEM

CERTEX OCT SPINAL IMPLANT SYSTEM is an FDA 510(k)-cleared medical device (K133094) 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 December 10, 2013. Regulation: 8.