AESCULAP SPINE SYSTEM EVOLUTION

AESCULAP SPINE SYSTEM EVOLUTION is an FDA 510(k)-cleared medical device (K980484) manufactured by Aesculap, 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 October 1, 1998. Regulation: 8.