FDA 510(k)

AxCess® Expandable Interbody System

Número K: K243739 · 2025-01-24

Data da decisão2025-01-24

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

AxCess® Expandable Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Elliquence, LLC. It received FDA 510(k) clearance on 2025-01-24 under 510(k) number K243739. 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 AxCess® Expandable Interbody System?

AxCess® Expandable Interbody System is a medical device that received FDA 510(k) clearance on 2025-01-24. The listed applicant is Elliquence, LLC. The 510(k) number is K243739.

When did AxCess® Expandable Interbody System receive FDA 510(k) clearance?

AxCess® Expandable Interbody System received FDA 510(k) clearance on 2025-01-24, under 510(k) number K243739.

Who is the listed applicant for AxCess® Expandable Interbody System?

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

What is the FDA product code for AxCess® Expandable Interbody System?

The FDA product code for AxCess® Expandable Interbody System is MAX.

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Dispositivos Relacionados (Código: MAX)

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Fonte oficial

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