ZIP™ MIS Interspinous Fusion System

ZIP™ MIS Interspinous Fusion System is an FDA 510(k)-cleared medical device (K221399) manufactured by Aurora Spine, 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 July 7, 2022. Regulation: 8.