SADDLE WITH ANCHOR, TITANIUM VARIFIX SYSTEM

SADDLE WITH ANCHOR, TITANIUM VARIFIX SYSTEM is an FDA 510(k)-cleared medical device (K953778) 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 November 5, 1995. Regulation: 8.