
Medtronic Sofamor Danek USA, Inc.
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MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER is an FDA 510(k)-cleared medical device (K010701) manufactured by Medtronic Sofamor Danek USA, Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 4, 2001. Regulation: 8.