TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION

TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION is an FDA 510(k)-cleared medical device (K933995) 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 January 26, 1995. Regulation: 8.