CENTRA-LINE GRAPPLE, VARIFIX SYSTEM

CENTRA-LINE GRAPPLE, VARIFIX SYSTEM is an FDA 510(k)-cleared medical device (K954770) 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 January 24, 1996. Regulation: 8.