
U&I Corp., America
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U&I, OPTIMA, SPINAL SYSTEM is an FDA 510(k)-cleared medical device (K031585) manufactured by U&I Corp., America. 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 26, 2003. Regulation: 8.