ORTHOPILOT NEXT GENERATION-UKA SOFTWARE, MODEL FS210

ORTHOPILOT NEXT GENERATION-UKA SOFTWARE, MODEL FS210 is an FDA 510(k)-cleared medical device (K090375) manufactured by Aesculap Implant System, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 22, 2009. Regulation: 8.