ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106

ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106 is an FDA 510(k)-cleared medical device (K080547) 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 May 22, 2008. Regulation: 8.