BIONX DISTAL RADIUS SCREW

BIONX DISTAL RADIUS SCREW is an FDA 510(k)-cleared medical device (K974876) manufactured by Bionx Implants, 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 March 19, 1998. Regulation: 8.