FDA 510(k)

Reliance Lumbar IBF System

Número K: K173283 · 2018-01-19

Data da decisão2018-01-19

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Reliance Lumbar IBF System is the device name listed in this FDA 510(k) record. The listed applicant is Reliance Medical Systems, LLC. It received FDA 510(k) clearance on 2018-01-19 under 510(k) number K173283. 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 Reliance Lumbar IBF System?

Reliance Lumbar IBF System is a medical device that received FDA 510(k) clearance on 2018-01-19. The listed applicant is Reliance Medical Systems, LLC. The 510(k) number is K173283.

When did Reliance Lumbar IBF System receive FDA 510(k) clearance?

Reliance Lumbar IBF System received FDA 510(k) clearance on 2018-01-19, under 510(k) number K173283.

Who is the listed applicant for Reliance Lumbar IBF System?

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

What is the FDA product code for Reliance Lumbar IBF System?

The FDA product code for Reliance Lumbar IBF System is MAX.

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Fonte oficial

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