AESCULAP PEEK CRANIOFIX

AESCULAP PEEK CRANIOFIX is an FDA 510(k)-cleared medical device (K091692) manufactured by Aesculap, 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 August 11, 2010. Regulation: 8.