FDA 510(k)

MPO Total Knee Systems MR Labeling

Número K: K152631 · 2016-03-23

Data da decisão2016-03-23

Código do produtoHRY

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

MPO Total Knee Systems MR Labeling is the device name listed in this FDA 510(k) record. The listed applicant is Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2016-03-23 under 510(k) number K152631. The device is classified under product code HRY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MPO Total Knee Systems MR Labeling?

MPO Total Knee Systems MR Labeling is a medical device that received FDA 510(k) clearance on 2016-03-23. The listed applicant is Microport Orthopedics, Inc.. The 510(k) number is K152631.

When did MPO Total Knee Systems MR Labeling receive FDA 510(k) clearance?

MPO Total Knee Systems MR Labeling received FDA 510(k) clearance on 2016-03-23, under 510(k) number K152631.

Who is the listed applicant for MPO Total Knee Systems MR Labeling?

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

What is the FDA product code for MPO Total Knee Systems MR Labeling?

The FDA product code for MPO Total Knee Systems MR Labeling is HRY.

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Outros registros que listam Microport Orthopedics, Inc. como candidato(a)

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