HOWMEDICA(R) FULLY THREADED SCREWS

HOWMEDICA(R) FULLY THREADED SCREWS is an FDA 510(k)-cleared medical device (K974720) manufactured by Howmedica, 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 March 12, 1998. Regulation: 8.