BROAD SELF-COMPRESSING PLATE

BROAD SELF-COMPRESSING PLATE is an FDA 510(k)-cleared medical device (K905355) manufactured by O'Tec 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 January 3, 1991. Regulation: 8.