FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM

FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K904340) manufactured by Neoligaments, Ltd.. 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 18, 1990. Regulation: 8.