FDA 510(k)

Solar Lumbar Interbody Fusion System

Número K: K231199 · 2023-06-16

Data da decisão2023-06-16

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Solar Lumbar Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Degen Medical. It received FDA 510(k) clearance on 2023-06-16 under 510(k) number K231199. 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 Solar Lumbar Interbody Fusion System?

Solar Lumbar Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2023-06-16. The listed applicant is Degen Medical. The 510(k) number is K231199.

When did Solar Lumbar Interbody Fusion System receive FDA 510(k) clearance?

Solar Lumbar Interbody Fusion System received FDA 510(k) clearance on 2023-06-16, under 510(k) number K231199.

Who is the listed applicant for Solar Lumbar Interbody Fusion System?

The FDA 510(k) record lists Degen Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Solar Lumbar Interbody Fusion System?

The FDA product code for Solar Lumbar Interbody Fusion System is MAX.

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Fonte oficial

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