510(k) K234059

Forma Medical Optimal Plating System by Forma Medical, Inc. — Product Code HRS

K234059 is an FDA 510(k) premarket notification submitted by Forma Medical, Inc. for the device "Forma Medical Optimal Plating System". The FDA issued a decision of Substantially Equivalent on June 26, 2024. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Forma Medical, Inc. has at least 1 other 510(k) clearance on record.