
Aesculap Implant Systems, Inc.
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COLUMBUS TOTAL KNEE SYSTEM MIOS CR/PS TIBIAL TRAY is an FDA 510(k)-cleared medical device (K071499) manufactured by Aesculap Implant Systems, 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 September 13, 2007. Regulation: 8.