510(k) K250613

SnapHammer Hammertoe Correction System by Nvision Biomedical Technologies, Inc. — Product Code HWC

K250613 is an FDA 510(k) premarket notification submitted by Nvision Biomedical Technologies, Inc. for the device "SnapHammer Hammertoe Correction System". The FDA issued a decision of Substantially Equivalent on April 2, 2025. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Nvision Biomedical Technologies, Inc. has at least 10 other 510(k) clearances on record.