FDA 510(k)

FortiVy™ OsteoVy™ Lumbar IBF

Número K: K241783 · 2025-03-18

Data da decisão2025-03-18

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

FortiVy™ OsteoVy™ Lumbar IBF 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 2025-03-18 under 510(k) number K241783. 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 FortiVy™ OsteoVy™ Lumbar IBF?

FortiVy™ OsteoVy™ Lumbar IBF is a medical device that received FDA 510(k) clearance on 2025-03-18. The listed applicant is Vy Spine, LLC. The 510(k) number is K241783.

When did FortiVy™ OsteoVy™ Lumbar IBF receive FDA 510(k) clearance?

FortiVy™ OsteoVy™ Lumbar IBF received FDA 510(k) clearance on 2025-03-18, under 510(k) number K241783.

Who is the listed applicant for FortiVy™ OsteoVy™ Lumbar IBF?

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 FortiVy™ OsteoVy™ Lumbar IBF?

The FDA product code for FortiVy™ OsteoVy™ Lumbar IBF is MAX.

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Outros registros que listam Vy Spine, LLC como candidato(a)

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Dispositivos Relacionados (Código: MAX)

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Fonte oficial

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