TORNIER TOTAL ELBOW PROSTHESIS

TORNIER TOTAL ELBOW PROSTHESIS is an FDA 510(k)-cleared medical device (K000003) manufactured by Tornier. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 1, 2000. Regulation: 8.