Ennovate Cervical Spinal and Occiput System

Ennovate Cervical Spinal and Occiput System is an FDA 510(k)-cleared medical device (K213871) manufactured by Aesculap Implant Systems, 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 June 30, 2022. Regulation: 8.