510(k) K111678

ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS by Ortho Solutions Limited — Product Code HRS

K111678 is an FDA 510(k) premarket notification submitted by Ortho Solutions Limited for the device "ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS". The FDA issued a decision of Substantially Equivalent on February 7, 2012. 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.