ARTOS, DIPLOS SYSTEM

ARTOS, DIPLOS SYSTEM is an FDA 510(k)-cleared medical device (K970284) 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 April 20, 1997. Regulation: 8.