
Howmedica Osteonics Corp.
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HOWMEDICA OSTEONICS SHOULDER SCREW is an FDA 510(k)-cleared medical device (K002654) 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 September 21, 2000. Regulation: 8.