ISOLA OPEN AND CLOSED SCREWS

ISOLA OPEN AND CLOSED SCREWS is an FDA 510(k)-cleared medical device (K944756) 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 May 29, 1995. Regulation: 8.