ULTIMAX ANKLE FUSION ROD SYSTEM

ULTIMAX ANKLE FUSION ROD SYSTEM is an FDA 510(k)-cleared medical device (K991790) manufactured by Encore Orthopedics, 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 August 5, 1999. Regulation: 8.