Corin BiPolar-i

Corin BiPolar-i is an FDA 510(k)-cleared medical device (K183114) manufactured by Corin U.S.A. Limited. 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 4, 2019. Regulation: 8.