Xenco Medical Pedicle Screw System

Xenco Medical Pedicle Screw System is an FDA 510(k)-cleared medical device (K160986) manufactured by Xenco Medical, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 3, 2016. Regulation: 8.