BACFIX SPINAL FIXATION SYSTEM

BACFIX SPINAL FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K964404) manufactured by Spinal Concepts, 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 March 25, 1997. Regulation: 8.