XENCO MEDICAL CERVICAL INTERBODY SYSTEM

XENCO MEDICAL CERVICAL INTERBODY SYSTEM is an FDA 510(k)-cleared medical device (K140786) 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 September 2, 2014. Regulation: 8.