
Medtronic Sofamor Danek
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CLYDESDALE SPINAL SYSTEM is an FDA 510(k)-cleared medical device (K083026) manufactured by Medtronic Sofamor Danek. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 28, 2008. Regulation: 8.