510(k) K253718

enHAnce PEEK Bunion System by Nvision Biomedical Technologies, Inc. — Product Code HRS

K253718 is an FDA 510(k) premarket notification submitted by Nvision Biomedical Technologies, Inc. for the device "enHAnce PEEK Bunion System". The FDA issued a decision of Substantially Equivalent on April 1, 2026. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Nvision Biomedical Technologies, Inc. has at least 10 other 510(k) clearances on record.