
Howmedica Osteonics Corp.
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TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT is an FDA 510(k)-cleared medical device (K090897) 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 October 22, 2009. Regulation: 8.