FDA 510(k)

MP Reconstruction System

Número K: K213675 · 2022-04-11

Data da decisão2022-04-11

Código do produtoLZO

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

MP Reconstruction System is the device name listed in this FDA 510(k) record. The listed applicant is Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2022-04-11 under 510(k) number K213675. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MP Reconstruction System?

MP Reconstruction System is a medical device that received FDA 510(k) clearance on 2022-04-11. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K213675.

When did MP Reconstruction System receive FDA 510(k) clearance?

MP Reconstruction System received FDA 510(k) clearance on 2022-04-11, under 510(k) number K213675.

Who is the listed applicant for MP Reconstruction System?

The FDA 510(k) record lists Waldemar Link GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MP Reconstruction System?

The FDA product code for MP Reconstruction System is LZO.

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Fonte oficial

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