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Biomet Orthopedics, Inc.
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CALCIGEN-S BONE VOID FILER is an FDA 510(k)-cleared medical device (K013790) manufactured by Biomet Orthopedics, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 10, 2002. Regulation: 8.