510(k) K230398

MedCAD® AccuPlate® 3DTi Patient-Specific Plating System by Medcad — Product Code JEY

K230398 is an FDA 510(k) premarket notification submitted by Medcad for the device "MedCAD® AccuPlate® 3DTi Patient-Specific Plating System". The FDA issued a decision of Substantially Equivalent on September 26, 2023. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Medcad has at least 8 other 510(k) clearances on record.