AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000

AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000 is an FDA 510(k)-cleared medical device (K981423) manufactured by Autogenesis, 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 May 19, 1998. Regulation: 8.