510(k) K240958

Locking Plates and Screws Systems by Hebei Ruihe Medical Devices Co., Ltd. — Product Code HRS

K240958 is an FDA 510(k) premarket notification submitted by Hebei Ruihe Medical Devices Co., Ltd. for the device "Locking Plates and Screws Systems". The FDA issued a decision of Substantially Equivalent on February 10, 2025. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030.