FDA 510(k)

SpineFrontier Lumbar Interbody Fusion Device System

Número K: K193106 · 2020-06-19

Data da decisão2020-06-19

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

SpineFrontier Lumbar Interbody Fusion Device System is the device name listed in this FDA 510(k) record. The listed applicant is Spinefrontier, Inc.. It received FDA 510(k) clearance on 2020-06-19 under 510(k) number K193106. 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 SpineFrontier Lumbar Interbody Fusion Device System?

SpineFrontier Lumbar Interbody Fusion Device System is a medical device that received FDA 510(k) clearance on 2020-06-19. The listed applicant is Spinefrontier, Inc.. The 510(k) number is K193106.

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

SpineFrontier Lumbar Interbody Fusion Device System received FDA 510(k) clearance on 2020-06-19, under 510(k) number K193106.

Who is the listed applicant for SpineFrontier Lumbar Interbody Fusion Device System?

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

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

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

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Fonte oficial

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