SLEEVE WITH ZIPLOOP FIXATION DEVICES

SLEEVE WITH ZIPLOOP FIXATION DEVICES is an FDA 510(k)-cleared medical device (K101063) manufactured by Biomet Sports Medicine. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 22, 2010. Regulation: 8.