SONGER(TM) CABLE SYSTEM

SONGER(TM) CABLE SYSTEM is an FDA 510(k)-cleared medical device (K913735) manufactured by Danek Medical, 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 November 17, 1991. Regulation: 8.