510(k) K122541

ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) by Orthofix Srl — Product Code KTW

K122541 is an FDA 510(k) premarket notification submitted by Orthofix Srl for the device "ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)". The FDA issued a decision of Substantially Equivalent on September 20, 2012. The device falls under product code KTW (Appliance, Fixation, Nail/Blade/Plate Combination, Single Component), a Class II device regulated under 21 CFR 888.3030. Orthofix Srl has at least 10 other 510(k) clearances on record.