MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15

MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15 is an FDA 510(k)-cleared medical device (K990845) manufactured by Advanced Spine Fixation Systems, 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 April 12, 1999. Regulation: 8.