TITANIUM CD HORIZON SPINAL SYSTEM

TITANIUM CD HORIZON SPINAL SYSTEM is an FDA 510(k)-cleared medical device (K962708) manufactured by Sofamor Danek USA,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 February 5, 1997. Regulation: 8.