PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM

PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM is an FDA 510(k)-cleared medical device (K061362) manufactured by Plus Orthopedics AG. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 5, 2006. Regulation: 8.