B-GENIN AND R-GENIN

B-GENIN AND R-GENIN is an FDA 510(k)-cleared medical device (K091912) manufactured by Berkeley Advanced Biomaterials, Inc.. 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 22, 2010. Regulation: 8.