
Omnlife Science
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APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210,303610,304010 is an FDA 510(k)-cleared medical device (K101575) manufactured by Omnlife Science. 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 29, 2010. Regulation: 8.