PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT

PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT is an FDA 510(k)-cleared medical device (K140900) manufactured by Stanmore Worldwide Implants , 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 February 11, 2015. Regulation: 8.