AMISTEM AND QUADRA - LINE EXTENSION

AMISTEM AND QUADRA - LINE EXTENSION is an FDA 510(k)-cleared medical device (K121011) manufactured by Medacta International. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 7, 2012. Regulation: 8.