MODIFICATIONS TO CD HORIZON SPINAL SYSTEM

MODIFICATIONS TO CD HORIZON SPINAL SYSTEM is an FDA 510(k)-cleared medical device (K063670) manufactured by Medtronic Sofamor Danek. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 27, 2007. Regulation: 8.