LIGAMENTOPLASTIC STAPLE OF L'UNION

LIGAMENTOPLASTIC STAPLE OF L'UNION is an FDA 510(k)-cleared medical device (K911020) manufactured by Sport Service, 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 May 28, 1991. Regulation: 8.