MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS

MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS is an FDA 510(k)-cleared medical device (K945115) manufactured by Biomet, 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 May 1, 1995. Regulation: 8.