OSTEOMED CRANIAL DISTRACTION SYSTEM

OSTEOMED CRANIAL DISTRACTION SYSTEM is an FDA 510(k)-cleared medical device (K121304) manufactured by Osteomed. 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 21, 2012. Regulation: 8.