
Lima Corporate S.P.A.
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MODULUS STEMS, MODULUS NECKS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS is an FDA 510(k)-cleared medical device (K112158) manufactured by Lima Corporate S.P.A.. 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 9, 2012. Regulation: 8.