MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280

MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280 is an FDA 510(k)-cleared medical device (K071791) manufactured by Codman & Shurtleff, 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 July 29, 2007. Regulation: 8.