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Stelkast Company
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EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM is an FDA 510(k)-cleared medical device (K122883) 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 August 4, 2013. Regulation: 8.