FDA 510(k)

Ventana® P/T Lumbar Interbody System

Número K: K260506 · 2026-05-15

Data da decisão2026-05-15

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ventana® P/T Lumbar Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Elements, Inc.. It received FDA 510(k) clearance on 2026-05-15 under 510(k) number K260506. 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 Ventana® P/T Lumbar Interbody System?

Ventana® P/T Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2026-05-15. The listed applicant is Spinal Elements, Inc.. The 510(k) number is K260506.

When did Ventana® P/T Lumbar Interbody System receive FDA 510(k) clearance?

Ventana® P/T Lumbar Interbody System received FDA 510(k) clearance on 2026-05-15, under 510(k) number K260506.

Who is the listed applicant for Ventana® P/T Lumbar Interbody System?

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

What is the FDA product code for Ventana® P/T Lumbar Interbody System?

The FDA product code for Ventana® P/T Lumbar Interbody System is MAX.

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Fonte oficial

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