TM ARDIS INTERBODY SYSTEM INSERTER

TM ARDIS INTERBODY SYSTEM INSERTER is an FDA 510(k)-cleared medical device (K123602) 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 February 28, 2013. Regulation: 8.