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Waldemar Link GmbH & Co. KG
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BETACONE HIP PROSTHESIS SYSTEM is an FDA 510(k)-cleared medical device (K051826) manufactured by Waldemar Link GmbH & Co. KG. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 17, 2005. Regulation: 8.