UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE

UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE is an FDA 510(k)-cleared medical device (K992570) manufactured by Howmedica 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 August 31, 1999. Regulation: 8.