STAPIX SUPERELASTIC IMPLANT BONE STAPLES

STAPIX SUPERELASTIC IMPLANT BONE STAPLES is an FDA 510(k)-cleared medical device (K133523) manufactured by Instratek, 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 February 5, 2014. Regulation: 8.