510(k) K230507

Zimed Distal Medial Tibial Plate and Screw System by Zimed Medikal — Product Code HWC

K230507 is an FDA 510(k) premarket notification submitted by Zimed Medikal for the device "Zimed Distal Medial Tibial Plate and Screw System". The FDA issued a decision of Substantially Equivalent on January 4, 2024. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040.