VARIAX DISTAL RADIUS PLATING SYSTEM

VARIAX DISTAL RADIUS PLATING SYSTEM is an FDA 510(k)-cleared medical device (K133974) manufactured by Stryker Leibinger 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 March 23, 2014. Regulation: 8.