
Aesculap Implant Systems, LLC
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COLUMBUS TOTAL KNEE SYSTEM AS COLUMBUS REVISION KNEE SYSTEM ENDURO KNEE SYSTEM is an FDA 510(k)-cleared medical device (K120955) manufactured by Aesculap Implant Systems, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 16, 2012. Regulation: 8.