ACRYL-X SYSTEM TM

ACRYL-X SYSTEM TM is an FDA 510(k)-cleared medical device (K911548) manufactured by Sonokinetics, 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 27, 1991. Regulation: 8.