LINK SADDLE PROTHESIS

LINK SADDLE PROTHESIS is an FDA 510(k)-cleared medical device (K951355) manufactured by Turnkey Intergration USA, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 24, 1995. Regulation: 8.