SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEM

SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K980288) manufactured by Spine-Tech, 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 July 28, 1998. Regulation: 8.