FDA 510(k)

Largo PEEK Interbody System

Número K: K193255 · 2020-02-20

Data da decisão2020-02-20

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Largo PEEK Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Flospine, LLC. It received FDA 510(k) clearance on 2020-02-20 under 510(k) number K193255. 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 Largo PEEK Interbody System?

Largo PEEK Interbody System is a medical device that received FDA 510(k) clearance on 2020-02-20. The listed applicant is Flospine, LLC. The 510(k) number is K193255.

When did Largo PEEK Interbody System receive FDA 510(k) clearance?

Largo PEEK Interbody System received FDA 510(k) clearance on 2020-02-20, under 510(k) number K193255.

Who is the listed applicant for Largo PEEK Interbody System?

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

What is the FDA product code for Largo PEEK Interbody System?

The FDA product code for Largo PEEK Interbody System is MAX.

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