ISOLA(TM) SPINE SYSTEM--EYE ROD

ISOLA(TM) SPINE SYSTEM--EYE ROD is an FDA 510(k)-cleared medical device (K911394) manufactured by Acromed Corp.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 20, 1991. Regulation: 8.