Aesculap OrthoPilot Next Generation

Aesculap OrthoPilot Next Generation is an FDA 510(k)-cleared medical device (K153396) manufactured by Aesculap Implant Systems, LLC. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 15, 2016. Regulation: 8.