TORNIER BIPOLAR RADIAL HEAD PROSTHESIS

TORNIER BIPOLAR RADIAL HEAD PROSTHESIS is an FDA 510(k)-cleared medical device (K994041) manufactured by Tornier, 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 August 30, 2000. Regulation: 8.