IOI COCR UNIPOLAR PROSTHESIS

IOI COCR UNIPOLAR PROSTHESIS is an FDA 510(k)-cleared medical device (K934159) manufactured by Intermedics Orthopedics. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 20, 1994. Regulation: 8.