ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)

ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) is an FDA 510(k)-cleared medical device (K122541) 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 19, 2012. Regulation: 8.