FDA 510(k)

Atlas Spine Project X Expandable Posterior Lumbar Interbody System

Número K: K251969 · 2025-08-15

Data da decisão2025-08-15

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Atlas Spine Project X Expandable Posterior Lumbar Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Atlas Spine, Inc.. It received FDA 510(k) clearance on 2025-08-15 under 510(k) number K251969. 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 Atlas Spine Project X Expandable Posterior Lumbar Interbody System?

Atlas Spine Project X Expandable Posterior Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2025-08-15. The listed applicant is Atlas Spine, Inc.. The 510(k) number is K251969.

When did Atlas Spine Project X Expandable Posterior Lumbar Interbody System receive FDA 510(k) clearance?

Atlas Spine Project X Expandable Posterior Lumbar Interbody System received FDA 510(k) clearance on 2025-08-15, under 510(k) number K251969.

Who is the listed applicant for Atlas Spine Project X Expandable Posterior Lumbar Interbody System?

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

What is the FDA product code for Atlas Spine Project X Expandable Posterior Lumbar Interbody System?

The FDA product code for Atlas Spine Project X Expandable Posterior Lumbar Interbody System is MAX.

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Outros registros que listam Atlas Spine, Inc. como candidato(a)

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Dispositivos Relacionados (Código: MAX)

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Fonte oficial

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