TRANSTIBIAL ACL DISPOSABLES KIT

TRANSTIBIAL ACL DISPOSABLES KIT is an FDA 510(k)-cleared medical device (K943943) 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 December 19, 1994. Regulation: 8.