510(k) K253178

TRILEAP Plating System by Crossroads Extremity Systems — Product Code HRS

K253178 is an FDA 510(k) premarket notification submitted by Crossroads Extremity Systems for the device "TRILEAP Plating System". The FDA issued a decision of Substantially Equivalent on January 6, 2026. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Crossroads Extremity Systems has at least 10 other 510(k) clearances on record.