FDA 510(k)

ARTFX Coluna Lombar Cages de PEEK

Número K: K240889 · 2024-10-02

Data da decisão2024-10-02

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

ARTFX Lumbar PEEK Cages is the device name listed in this FDA 510(k) record. The listed applicant is Artfx Medical. It received FDA 510(k) clearance on 2024-10-02 under 510(k) number K240889. 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 ARTFX Lumbar PEEK Cages?

ARTFX Lumbar PEEK Cages is a medical device that received FDA 510(k) clearance on 2024-10-02. The listed applicant is Artfx Medical. The 510(k) number is K240889.

When did ARTFX Lumbar PEEK Cages receive FDA 510(k) clearance?

ARTFX Lumbar PEEK Cages received FDA 510(k) clearance on 2024-10-02, under 510(k) number K240889.

Who is the listed applicant for ARTFX Lumbar PEEK Cages?

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

What is the FDA product code for ARTFX Lumbar PEEK Cages?

The FDA product code for ARTFX Lumbar PEEK Cages is MAX.

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Fonte oficial

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