510(k) K233873

XLO Brand of Locking Distal Humerus Plating System by Ortho Life Systems Private Limited — Product Code HRS

K233873 is an FDA 510(k) premarket notification submitted by Ortho Life Systems Private Limited for the device "XLO Brand of Locking Distal Humerus Plating System". The FDA issued a decision of Substantially Equivalent on April 26, 2024. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030.