FDA 510(k)

Sistema Lombar Advantage - ALIF, PLIF, DLIF, TLIF

Número K: K212389 · 2021-10-29

Data da decisão2021-10-29

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF is the device name listed in this FDA 510(k) record. The listed applicant is Intelivation, LLC. It received FDA 510(k) clearance on 2021-10-29 under 510(k) number K212389. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF?

Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF is a medical device that received FDA 510(k) clearance on 2021-10-29. The listed applicant is Intelivation, LLC. The 510(k) number is K212389.

When did Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF receive FDA 510(k) clearance?

Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF received FDA 510(k) clearance on 2021-10-29, under 510(k) number K212389.

Who is the listed applicant for Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF?

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

What is the FDA product code for Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF?

The FDA product code for Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF is MAX.

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Fonte oficial

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