
Lima-Lto S.P.A.
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LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES, is an FDA 510(k)-cleared medical device (K100858) manufactured by Lima-Lto 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 December 9, 2010. Regulation: 8.