510(k) K230591

TriLEAP Plating System by Crossroads Extremity Systems — Product Code HRS

K230591 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 September 29, 2023. 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.