TITANIUM GDLH POSTERIOR SPINAL SYSTEM

TITANIUM GDLH POSTERIOR SPINAL SYSTEM is an FDA 510(k)-cleared medical device (K954645) 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 January 15, 1996. Regulation: 8.