510(k) K252997

HyperFlex® Bunion Correction System by Hyperflex Medical — Product Code HRS

K252997 is an FDA 510(k) premarket notification submitted by Hyperflex Medical for the device "HyperFlex® Bunion Correction System". The FDA issued a decision of Substantially Equivalent on Dec 11, 2025. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030.