510(k) K190388

RIVAL View Plating Systems and Reduce Fracture Plating Systems by Orthofix Srl — Product Code HRS

K190388 is an FDA 510(k) premarket notification submitted by Orthofix Srl for the device "RIVAL View Plating Systems and Reduce Fracture Plating Systems". The FDA issued a decision of Substantially Equivalent on Jun 7, 2019. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Orthofix Srl has 97 other 510(k) clearances on record.