ZIP MIS INTERSPINOUS FUSION SYSTEM

ZIP MIS INTERSPINOUS FUSION SYSTEM is an FDA 510(k)-cleared medical device (K133091) manufactured by Aurora Spine. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 26, 2013. Regulation: 8.