MONDEAL DISTAL RADIUS SYSTEM

MONDEAL DISTAL RADIUS SYSTEM is an FDA 510(k)-cleared medical device (K071798) manufactured by Mondeal Medical Systems GmbH. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 16, 2007. Regulation: 8.