
Medtronic Sofamor Danek, Inc.
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TSRH SPINAL SYSTEM is an FDA 510(k)-cleared medical device (K032578) 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 September 16, 2003. Regulation: 8.