FDA 510(k)

Vortex5 Tailor's Bunion Correction System

N.º K: K260291 · 2026-03-25

SolicitanteNvision Biomedical Technologies, Inc.

Fecha de decisión2026-03-25

Código de productoHRS

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

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

Preguntas frecuentes

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. The listed applicant is Nvision Biomedical Technologies, Inc.. The 510(k) number is K260291.

When did Vortex5 Tailor's Bunion Correction System receive FDA 510(k) clearance?

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

Who is the listed applicant for Vortex5 Tailor's Bunion Correction System?

The FDA 510(k) record lists Nvision Biomedical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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Fuente oficial

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