DUAL ROD ANTERIOR FIXATOR SYSTEM

DUAL ROD ANTERIOR FIXATOR SYSTEM is an FDA 510(k)-cleared medical device (K963780) 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 July 29, 1997. Regulation: 8.