PATIENT SPECIFIC DISTAL FEMORAL

PATIENT SPECIFIC DISTAL FEMORAL is an FDA 510(k)-cleared medical device (K140898) 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 January 19, 2015. Regulation: 8.