TRUE/ FLEX FIBULA RODS

TRUE/ FLEX FIBULA RODS is an FDA 510(k)-cleared medical device (K924656) manufactured by Applied Osteo Systems, 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 23, 1992. Regulation: 8.