MAALEABLE FACIAL IMPLANT

MAALEABLE FACIAL IMPLANT is an FDA 510(k)-cleared medical device (K915445) manufactured by Biomet Ussc Orthopedics. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 2, 1992. Regulation: 8.