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Kelyniam Global, Inc.
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CUSTOM CRANIOFACIAL IMPLANT (CCI) is an FDA 510(k)-cleared medical device (K121755) manufactured by Kelyniam Global, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 24, 2012. Regulation: 8.