
Medtronic Sofamor Danek USA
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PERIMETER INTERBODY FUSION DEVICE is an FDA 510(k)-cleared medical device (K113642) manufactured by Medtronic Sofamor Danek USA. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 5, 2012. Regulation: 8.