MODIFICATION TO BONE MULCH SCREW SYSTEM

MODIFICATION TO BONE MULCH SCREW SYSTEM is an FDA 510(k)-cleared medical device (K993025) 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 7, 1999. Regulation: 8.