ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER

ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER is an FDA 510(k)-cleared medical device (K961649) manufactured by Smith & Nephew Endoscopy, 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 July 15, 1996. Regulation: 8.