FDA 510(k)

LumiVy™ Lumbar IBF System

Número K: K233807 · 2024-09-24

Data da decisão2024-09-24

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

LumiVy™ Lumbar IBF System is the device name listed in this FDA 510(k) record. The listed applicant is Vy Spine, LLC. It received FDA 510(k) clearance on 2024-09-24 under 510(k) number K233807. 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 LumiVy™ Lumbar IBF System?

LumiVy™ Lumbar IBF System is a medical device that received FDA 510(k) clearance on 2024-09-24. The listed applicant is Vy Spine, LLC. The 510(k) number is K233807.

When did LumiVy™ Lumbar IBF System receive FDA 510(k) clearance?

LumiVy™ Lumbar IBF System received FDA 510(k) clearance on 2024-09-24, under 510(k) number K233807.

Who is the listed applicant for LumiVy™ Lumbar IBF System?

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

What is the FDA product code for LumiVy™ Lumbar IBF System?

The FDA product code for LumiVy™ Lumbar IBF System is MAX.

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Dispositivos Relacionados (Código: MAX)

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Fonte oficial

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