ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS

ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS is an FDA 510(k)-cleared medical device (K141509) manufactured by Medos Sarl. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 21, 2014. Regulation: 8.