TITANIUM SPINAL ROD SYSTEM

TITANIUM SPINAL ROD SYSTEM is an FDA 510(k)-cleared medical device (K980862) manufactured by United States Surgical, A Division of Tyco Healthc. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 19, 1998. Regulation: 8.