ALPHA ORTHOPAEDICS AT2 SYSTEM

ALPHA ORTHOPAEDICS AT2 SYSTEM is an FDA 510(k)-cleared medical device (K120527) manufactured by Alpha Orthopaedics, Inc.. 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 June 17, 2012. Regulation: 8.