TITANIUM ALLOY SONGER CABLE SYSTEM

TITANIUM ALLOY SONGER CABLE SYSTEM is an FDA 510(k)-cleared medical device (K920201) manufactured by Sofamor Danek Mfg., 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 April 7, 1992. Regulation: 8.