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Omni Life Science, Inc.
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APEX KNEE SYSTEM, APEX ALL POLY TIBIA is an FDA 510(k)-cleared medical device (K111062) manufactured by Omni Life Science, 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 July 12, 2011. Regulation: 8.