FDA 510(k)

Contour Knee

Número K: K223429 · 2023-01-13

Data da decisão2023-01-13

Código do produtoMOS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Contour Knee is the device name listed in this FDA 510(k) record. The listed applicant is Quality Electrodynamics, LLC. It received FDA 510(k) clearance on 2023-01-13 under 510(k) number K223429. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Contour Knee?

Contour Knee is a medical device that received FDA 510(k) clearance on 2023-01-13. The listed applicant is Quality Electrodynamics, LLC. The 510(k) number is K223429.

When did Contour Knee receive FDA 510(k) clearance?

Contour Knee received FDA 510(k) clearance on 2023-01-13, under 510(k) number K223429.

Who is the listed applicant for Contour Knee?

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

What is the FDA product code for Contour Knee?

The FDA product code for Contour Knee is MOS.

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Fonte oficial

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