OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR

OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR is an FDA 510(k)-cleared medical device (K123885) manufactured by Osteomed LP. 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 2, 2013. Regulation: 8.