FDA 510(k)

Varion Thoracolumbar Fixation System

Número K: K260989 · 2026-05-15

RequerenteKyocera Medical Technologies Inc. (KMTI)

Data da decisão2026-05-15

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Varion Thoracolumbar Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Kyocera Medical Technologies Inc. (KMTI). It received FDA 510(k) clearance on 2026-05-15 under 510(k) number K260989. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Varion Thoracolumbar Fixation System?

Varion Thoracolumbar Fixation System is a medical device that received FDA 510(k) clearance on 2026-05-15. The listed applicant is Kyocera Medical Technologies Inc. (KMTI). The 510(k) number is K260989.

When did Varion Thoracolumbar Fixation System receive FDA 510(k) clearance?

Varion Thoracolumbar Fixation System received FDA 510(k) clearance on 2026-05-15, under 510(k) number K260989.

Who is the listed applicant for Varion Thoracolumbar Fixation System?

The FDA 510(k) record lists Kyocera Medical Technologies Inc. (KMTI) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Varion Thoracolumbar Fixation System?

The FDA product code for Varion Thoracolumbar Fixation System is NKB.

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Fonte oficial

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