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Maxx Orthopedics, Inc.
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FREEDOM(R) STEMMED TIBIAL COMPONENTS is an FDA 510(k)-cleared medical device (K111785) manufactured by Maxx Orthopedics, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 28, 2012. Regulation: 8.