
Howmedica Osteonics Corp.
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SECUR-FIT MAX AND PLUS MAX HIP STEMS is an FDA 510(k)-cleared medical device (K051738) 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 July 18, 2005. Regulation: 8.