
Depuy Orthopaedics
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DEPUY M-SPEC 36MM FEMORAL HEADS is an FDA 510(k)-cleared medical device (K120599) manufactured by Depuy Orthopaedics. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 29, 2013. Regulation: 8.