ISOLA SPINE SYSTEM: PLATE-ROD COMBINATION

ISOLA SPINE SYSTEM: PLATE-ROD COMBINATION is an FDA 510(k)-cleared medical device (K920392) 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 December 30, 1992. Regulation: 8.