SILHOUETTE SPINAL FIXATION SYSTEM

SILHOUETTE SPINAL FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K993067) manufactured by Sulzer Spine-Tech. 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 15, 1999. Regulation: 8.