Arrowhead Mini-Rail Fixator

Arrowhead Mini-Rail Fixator is an FDA 510(k)-cleared medical device (K162032) manufactured by Arrowhead De, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 20, 2017. Regulation: 8.