PLUS BIPOLAR PROSTHESIS COCRMO

PLUS BIPOLAR PROSTHESIS COCRMO is an FDA 510(k)-cleared medical device (K982447) manufactured by Plus 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 November 24, 1998. Regulation: 8.