FDA 510(k)

SIRION Lateral Lumbar Interbody System

Número K: K223335 · 2023-05-09

Data da decisão2023-05-09

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

SIRION Lateral Lumbar Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Astura Medical. It received FDA 510(k) clearance on 2023-05-09 under 510(k) number K223335. 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 SIRION Lateral Lumbar Interbody System?

SIRION Lateral Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2023-05-09. The listed applicant is Astura Medical. The 510(k) number is K223335.

When did SIRION Lateral Lumbar Interbody System receive FDA 510(k) clearance?

SIRION Lateral Lumbar Interbody System received FDA 510(k) clearance on 2023-05-09, under 510(k) number K223335.

Who is the listed applicant for SIRION Lateral Lumbar Interbody System?

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

What is the FDA product code for SIRION Lateral Lumbar Interbody System?

The FDA product code for SIRION Lateral Lumbar Interbody System is MAX.

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Fonte oficial

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