DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM

DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K012173) 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 September 27, 2001. Regulation: 8.