
Aesculap
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CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM is an FDA 510(k)-cleared medical device (K040864) manufactured by Aesculap. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 16, 2004. Regulation: 8.