
Medtronic Sofamor Danek, Inc.
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CD HORIZON SPINAL SYSTEM, 4.5 ROD FOR POSTERIOR APPLICATION is an FDA 510(k)-cleared medical device (K010181) manufactured by Medtronic Sofamor Danek, 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 11, 2001. Regulation: 8.