ISOLA POLYAXIAL WASHER

ISOLA POLYAXIAL WASHER is an FDA 510(k)-cleared medical device (K013441) manufactured by Depuyacromed. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 15, 2001. Regulation: 8.