
Omnlife Science
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APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM) is an FDA 510(k)-cleared medical device (K100151) 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 May 27, 2010. Regulation: 8.