
Centerpulse Orthopedics, Inc.
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TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE is an FDA 510(k)-cleared medical device (K031183) manufactured by Centerpulse Orthopedics, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 13, 2003. Regulation: 8.