
Orthofix Srl
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ORTHOFIX GALAXY FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K113770) manufactured by Orthofix Srl. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 3, 2012. Regulation: 8.