FDA 510(k)

Sistema Interbody Adaptix com Tecnologia de Superfície Titan nanoLOCK

Número K: K201267 · 2020-08-26

Data da decisão2020-08-26

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Adaptix Interbody System with Titan nanoLOCK Surface Technology is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek. It received FDA 510(k) clearance on 2020-08-26 under 510(k) number K201267. 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 Adaptix Interbody System with Titan nanoLOCK Surface Technology?

Adaptix Interbody System with Titan nanoLOCK Surface Technology is a medical device that received FDA 510(k) clearance on 2020-08-26. The listed applicant is Medtronic Sofamor Danek. The 510(k) number is K201267.

When did Adaptix Interbody System with Titan nanoLOCK Surface Technology receive FDA 510(k) clearance?

Adaptix Interbody System with Titan nanoLOCK Surface Technology received FDA 510(k) clearance on 2020-08-26, under 510(k) number K201267.

Who is the listed applicant for Adaptix Interbody System with Titan nanoLOCK Surface Technology?

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

What is the FDA product code for Adaptix Interbody System with Titan nanoLOCK Surface Technology?

The FDA product code for Adaptix Interbody System with Titan nanoLOCK Surface Technology is MAX.

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Fonte oficial

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