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Wrightmedicaltechnologyinc
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PROFEMUR Z REVISION HIP STEM is an FDA 510(k)-cleared medical device (K121221) manufactured by Wrightmedicaltechnologyinc. 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 8, 2012. Regulation: 8.