FDA 510(k)

Aries® Lumbar Interbodies

Número K: K181347 · 2018-08-15

Data da decisão2018-08-15

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Aries® Lumbar Interbodies is the device name listed in this FDA 510(k) record. The listed applicant is Osseus Fusion Systems, LLC. It received FDA 510(k) clearance on 2018-08-15 under 510(k) number K181347. 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 Aries® Lumbar Interbodies?

Aries® Lumbar Interbodies is a medical device that received FDA 510(k) clearance on 2018-08-15. The listed applicant is Osseus Fusion Systems, LLC. The 510(k) number is K181347.

When did Aries® Lumbar Interbodies receive FDA 510(k) clearance?

Aries® Lumbar Interbodies received FDA 510(k) clearance on 2018-08-15, under 510(k) number K181347.

Who is the listed applicant for Aries® Lumbar Interbodies?

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

What is the FDA product code for Aries® Lumbar Interbodies?

The FDA product code for Aries® Lumbar Interbodies is MAX.

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Fonte oficial

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