
Ascension Orthopedic
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TITAN MODULAR TOTAL SHOULDER SYSTEM is an FDA 510(k)-cleared medical device (K112438) manufactured by Ascension Orthopedic. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 10, 2012. Regulation: 8.