ALPHA ORTHOPAEDICS AT3 SYSTEM

ALPHA ORTHOPAEDICS AT3 SYSTEM is an FDA 510(k)-cleared medical device (K094041) manufactured by Alpha Orthopaedics. 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 April 6, 2010. Regulation: 8.