FASTLOK (STAPLE & BUCKLE) FIXATION SYSTEM

FASTLOK (STAPLE & BUCKLE) FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K913461) 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 14, 1991. Regulation: 8.