FDA 510(k)

Inspan ScrewLES Fusion System

Número K: K213266 · 2021-12-03

Data da decisão2021-12-03

Código do produtoPEK

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Inspan ScrewLES Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Lespine Innovations, LLC. It received FDA 510(k) clearance on 2021-12-03 under 510(k) number K213266. The device is classified under product code PEK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Inspan ScrewLES Fusion System?

Inspan ScrewLES Fusion System is a medical device that received FDA 510(k) clearance on 2021-12-03. The listed applicant is Lespine Innovations, LLC. The 510(k) number is K213266.

When did Inspan ScrewLES Fusion System receive FDA 510(k) clearance?

Inspan ScrewLES Fusion System received FDA 510(k) clearance on 2021-12-03, under 510(k) number K213266.

Who is the listed applicant for Inspan ScrewLES Fusion System?

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

What is the FDA product code for Inspan ScrewLES Fusion System?

The FDA product code for Inspan ScrewLES Fusion System is PEK.

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