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Ceremed , Inc.
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CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K051293) manufactured by Ceremed , Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 13, 2005. Regulation: 8.