
Stelkast Company
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PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERT is an FDA 510(k)-cleared medical device (K031901) manufactured by Stelkast Company. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 9, 2003. Regulation: 8.