DANEK PLATE AND SCREW SYSTEM

DANEK PLATE AND SCREW SYSTEM is an FDA 510(k)-cleared medical device (K991036) 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 September 13, 1999. Regulation: 8.