
Zimmer Trabecular Metal Technology
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TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION is an FDA 510(k)-cleared medical device (K113561) manufactured by Zimmer Trabecular Metal Technology. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 28, 2012. Regulation: 8.