
Howmedica Osteonics Corp.
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36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS is an FDA 510(k)-cleared medical device (K031730) manufactured by Howmedica Osteonics Corp.. 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 28, 2003. Regulation: 8.