Zimmer Biomet Universal Navigation System

Zimmer Biomet Universal Navigation System is an FDA 510(k)-cleared medical device (K192133) manufactured by Zimmer Biomet Spine, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 28, 2019. Regulation: 8.