510(k) K251913

OsteoCentric® UnifiMI® TCS Plating System by OsteoCentric Technologies — Product Code HRS

K251913 is an FDA 510(k) premarket notification submitted by OsteoCentric Technologies for the device "OsteoCentric® UnifiMI® TCS Plating System". The FDA issued a decision of Substantially Equivalent on August 16, 2025. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. OsteoCentric Technologies has at least 10 other 510(k) clearances on record.