EXACTECH BIPOLAR HIP PROSTHESIS

EXACTECH BIPOLAR HIP PROSTHESIS is an FDA 510(k)-cleared medical device (K905370) manufactured by Exactech, 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 February 26, 1991. Regulation: 8.