Elite SPK, Compasso, Elite SPK Kit

Elite SPK, Compasso, Elite SPK Kit is an FDA 510(k)-cleared medical device (K160500) manufactured by Ncs Lab Srl. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 19, 2016. Regulation: 8.