
Medtronic Sofamor Danek
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MASTERGRAFT PUTTY is an FDA 510(k)-cleared medical device (K081784) manufactured by Medtronic Sofamor Danek. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 16, 2008. Regulation: 8.