SCULPTOR ROBOTIC GUIDANCE ARM (RGA)

SCULPTOR ROBOTIC GUIDANCE ARM (RGA) is an FDA 510(k)-cleared medical device (K121765) manufactured by Stanmore Implants Worldwide , Ltd.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 10, 2013. Regulation: 8.