510(k) K251361

Tyber Medical Distal Radius Plating System by Tyber Medical, LLC — Product Code HRS

K251361 is an FDA 510(k) premarket notification submitted by Tyber Medical, LLC for the device "Tyber Medical Distal Radius Plating System". The FDA issued a decision of Substantially Equivalent on July 30, 2025. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Tyber Medical, LLC has at least 10 other 510(k) clearances on record.