FDA 510(k)

HALF DOME Posterior Lumbar Interbody System

Número K: K172947 · 2018-04-18

Data da decisão2018-04-18

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

HALF DOME Posterior 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 2018-04-18 under 510(k) number K172947. 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 HALF DOME Posterior Lumbar Interbody System?

HALF DOME Posterior Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2018-04-18. The listed applicant is Astura Medical. The 510(k) number is K172947.

When did HALF DOME Posterior Lumbar Interbody System receive FDA 510(k) clearance?

HALF DOME Posterior Lumbar Interbody System received FDA 510(k) clearance on 2018-04-18, under 510(k) number K172947.

Who is the listed applicant for HALF DOME Posterior 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 HALF DOME Posterior Lumbar Interbody System?

The FDA product code for HALF DOME Posterior Lumbar Interbody System is MAX.

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Fonte oficial

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