510(k) K252356

The Acumed Wrist Fixation System - 2.4mm Screws by Acumed, LLC — Product Code HRS

K252356 is an FDA 510(k) premarket notification submitted by Acumed, LLC for the device "The Acumed Wrist Fixation System - 2.4mm Screws". The FDA issued a decision of Substantially Equivalent on August 21, 2025. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Acumed, LLC has at least 10 other 510(k) clearances on record.