METS MODULAR DISTAL FEMUR

METS MODULAR DISTAL FEMUR is an FDA 510(k)-cleared medical device (K121029) manufactured by Stanmore Implants Worldwide , Ltd.. 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 18, 2012. Regulation: 8.