OSTEONICS ELBOW PROSTHESIS

OSTEONICS ELBOW PROSTHESIS is an FDA 510(k)-cleared medical device (K861680) manufactured by Osteonics Corp.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 26, 1986. Regulation: 8.