
Plus Orthopedics
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VKS/TC-PLUS REVISION KNEE is an FDA 510(k)-cleared medical device (K032215) manufactured by Plus Orthopedics. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 7, 2003. Regulation: 8.