TITANIUM DYNA-LOK SPINAL SYSTEM

TITANIUM DYNA-LOK SPINAL SYSTEM is an FDA 510(k)-cleared medical device (K953635) 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 October 29, 1995. Regulation: 8.