FDA 510(k)

Centerpiece Plate Fixation System

Número K: K212428 · 2021-12-13

Data da decisão2021-12-13

Código do produtoNQW

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Centerpiece Plate Fixation System 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 2021-12-13 under 510(k) number K212428. The device is classified under product code NQW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Centerpiece Plate Fixation System?

Centerpiece Plate Fixation System is a medical device that received FDA 510(k) clearance on 2021-12-13. The listed applicant is Medtronic Sofamor Danek. The 510(k) number is K212428.

When did Centerpiece Plate Fixation System receive FDA 510(k) clearance?

Centerpiece Plate Fixation System received FDA 510(k) clearance on 2021-12-13, under 510(k) number K212428.

Who is the listed applicant for Centerpiece Plate Fixation System?

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 Centerpiece Plate Fixation System?

The FDA product code for Centerpiece Plate Fixation System is NQW.

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Fonte oficial

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