510(k) K141784

ORTHO SOLUTIONS ULTOS PLATING SYSTEM by Ortho Solutions Limited — Product Code HRS

K141784 is an FDA 510(k) premarket notification submitted by Ortho Solutions Limited for the device "ORTHO SOLUTIONS ULTOS PLATING SYSTEM". The FDA issued a decision of Substantially Equivalent on July 23, 2014. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Ortho Solutions Limited has at least 5 other 510(k) clearances on record.