ARTHREX CHONDRAL DART, MODEL AR-4005B-18

ARTHREX CHONDRAL DART, MODEL AR-4005B-18 is an FDA 510(k)-cleared medical device (K991971) manufactured by Arthrex, 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 August 3, 2000. Regulation: 8.