Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve

Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve is an FDA 510(k)-cleared medical device (K212431) 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 February 6, 2022. Regulation: 8.