FDA 510(k)

sagAlign Lumbar Cage System (Various PNs)

Número K: K241413 · 2024-07-17

Data da decisão2024-07-17

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

sagAlign Lumbar Cage System (Various PNs) is the device name listed in this FDA 510(k) record. The listed applicant is Acuity Surgical Devices, LLC. It received FDA 510(k) clearance on 2024-07-17 under 510(k) number K241413. 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 sagAlign Lumbar Cage System (Various PNs)?

sagAlign Lumbar Cage System (Various PNs) is a medical device that received FDA 510(k) clearance on 2024-07-17. The listed applicant is Acuity Surgical Devices, LLC. The 510(k) number is K241413.

When did sagAlign Lumbar Cage System (Various PNs) receive FDA 510(k) clearance?

sagAlign Lumbar Cage System (Various PNs) received FDA 510(k) clearance on 2024-07-17, under 510(k) number K241413.

Who is the listed applicant for sagAlign Lumbar Cage System (Various PNs)?

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

What is the FDA product code for sagAlign Lumbar Cage System (Various PNs)?

The FDA product code for sagAlign Lumbar Cage System (Various PNs) is MAX.

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Fonte oficial

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