ZIRCONIA CERAMIC MODULAR HEADS (ASTRO MET)

ZIRCONIA CERAMIC MODULAR HEADS (ASTRO MET) is an FDA 510(k)-cleared medical device (K943586) 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 October 16, 1994. Regulation: 8.