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Medacta International S.A.
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MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA C is an FDA 510(k)-cleared medical device (K083558) manufactured by Medacta International S.A.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 5, 2009. Regulation: 8.