AUTOGENESIS(TM) AUTOMATOR

AUTOGENESIS(TM) AUTOMATOR is an FDA 510(k)-cleared medical device (K905514) manufactured by Advanced Biosearch Assn.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 1, 1991. Regulation: 8.