510(k) K250494

The OsteoCentric Bone Plate and Screw System by OsteoCentric Technologies — Product Code HRS

K250494 is an FDA 510(k) premarket notification submitted by OsteoCentric Technologies for the device "The OsteoCentric Bone Plate and Screw System". The FDA issued a decision of Substantially Equivalent on March 18, 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.