ACCELL EVO3 (FORMERLY ACCELL A2I)

ACCELL EVO3 (FORMERLY ACCELL A2I) is an FDA 510(k)-cleared medical device (K103742) manufactured by Integra Life Sciences. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 16, 2011. Regulation: 8.