
Medtronic Sofamor Danek, Inc.
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DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM is an FDA 510(k)-cleared medical device (K012081) 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 30, 2001. Regulation: 8.