Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments

Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments is an FDA 510(k)-cleared medical device (K153700) 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 July 7, 2016. Regulation: 8.