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FDA 510(k)

Vortex5 Tailor's Bunion Correction System

K-Number: K260291 · 2026-03-25

ApplicantNvision Biomedical Technologies, Inc.
Decision Date2026-03-25
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Vortex5 Tailor's Bunion Correction System is a medical device manufactured by Nvision Biomedical Technologies, Inc.. It received FDA 510(k) clearance on 2026-03-25 under approval number K260291. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vortex5 Tailor's Bunion Correction System?

Vortex5 Tailor's Bunion Correction System is a medical device that received FDA 510(k) clearance on 2026-03-25. It is manufactured by Nvision Biomedical Technologies, Inc.. The 510(k) number is K260291.

When was Vortex5 Tailor's Bunion Correction System approved by the FDA?

Vortex5 Tailor's Bunion Correction System received FDA 510(k) clearance on 2026-03-25, under approval number K260291.

What company makes Vortex5 Tailor's Bunion Correction System?

Vortex5 Tailor's Bunion Correction System is manufactured by Nvision Biomedical Technologies, Inc..

What is the FDA product code for Vortex5 Tailor's Bunion Correction System?

The FDA product code for Vortex5 Tailor's Bunion Correction System is HRS.

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Other Devices by Nvision Biomedical Technologies, Inc.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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