OSTEONICS UNIPOLAR ENDO HEAD

OSTEONICS UNIPOLAR ENDO HEAD is an FDA 510(k)-cleared medical device (K954534) 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 November 29, 1995. Regulation: 8.