Xenco Medical Cervical Interbody System, Xenco Medical Lumbar Interbody System

Xenco Medical Cervical Interbody System, Xenco Medical Lumbar Interbody System is an FDA 510(k)-cleared medical device (K152987) 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 December 10, 2015. Regulation: 8.