MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM

MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K020196) 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 February 14, 2002. Regulation: 8.