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Integra LifeSciences Corporation
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MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114 is an FDA 510(k)-cleared medical device (K090506) manufactured by Integra LifeSciences Corporation. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 19, 2009. Regulation: 8.