TRIPLE-FIX SPINAL FIXATION SYSTEM

TRIPLE-FIX SPINAL FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K992147) manufactured by Advanced Spine Technology, 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 February 27, 2000. Regulation: 8.