MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM

MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K991460) manufactured by Sofamor Danek. 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 18, 1999. Regulation: 8.