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Howmedica Osteonics Corp.
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ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM is an FDA 510(k)-cleared medical device (K023102) 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 8, 2002. Regulation: 8.