510(k) K261038

Xpert PFP by Newclip Technics — Product Code HRS

K261038 is an FDA 510(k) premarket notification submitted by Newclip Technics for the device "Xpert PFP". The FDA issued a decision of Substantially Equivalent on May 29, 2026. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Newclip Technics has at least 10 other 510(k) clearances on record.