FDA 510(k)

Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)

Número K: K251073 · 2025-07-23

Data da decisão2025-07-23

Código do produtoOLO

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) is the device name listed in this FDA 510(k) record. The listed applicant is Innovasis, Inc.. It received FDA 510(k) clearance on 2025-07-23 under 510(k) number K251073. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)?

Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) is a medical device that received FDA 510(k) clearance on 2025-07-23. The listed applicant is Innovasis, Inc.. The 510(k) number is K251073.

When did Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) receive FDA 510(k) clearance?

Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) received FDA 510(k) clearance on 2025-07-23, under 510(k) number K251073.

Who is the listed applicant for Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)?

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

What is the FDA product code for Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)?

The FDA product code for Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) is OLO.

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Fonte oficial

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