ARTHRO-FLOW IRRIGATION 2 SYSTEM

ARTHRO-FLOW IRRIGATION 2 SYSTEM is an FDA 510(k)-cleared medical device (K913028) manufactured by Davol, 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 9, 1991. Regulation: 8.