PIGALILEO TKR BASE V2.3 AND CAS V4.1

PIGALILEO TKR BASE V2.3 AND CAS V4.1 is an FDA 510(k)-cleared medical device (K090313) manufactured by Smith & Nephew, 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 March 10, 2009. Regulation: 8.