
Osteonics Corp.
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OSTEONICS NORMALIZED AD ACETABULAR COMPONENT SYSTEM is an FDA 510(k)-cleared medical device (K970697) manufactured by 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 April 23, 1997. Regulation: 8.

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