DISTAL RADIO-ULNAR JOINT IMPLANT

DISTAL RADIO-ULNAR JOINT IMPLANT is an FDA 510(k)-cleared medical device (K040497) manufactured by Aptis Medical, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 25, 2005. Regulation: 8.