TRABECULAR METAL KNEE SYSTEM AUGMENTS

TRABECULAR METAL KNEE SYSTEM AUGMENTS is an FDA 510(k)-cleared medical device (K040487) manufactured by Implex Corp.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 20, 2004. Regulation: 8.