
Plus Orthopedics
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TC-PLUS POROUS TIBIAL COMPONENTS is an FDA 510(k)-cleared medical device (K011288) 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 May 23, 2001. Regulation: 8.