FDA 510(k)

Symmetric Total Knee System

Número K: K203779 · 2021-06-10

Data da decisão2021-06-10

Código do produtoMBH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Symmetric Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Signal Medical Corporation. It received FDA 510(k) clearance on 2021-06-10 under 510(k) number K203779. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Symmetric Total Knee System?

Symmetric Total Knee System is a medical device that received FDA 510(k) clearance on 2021-06-10. The listed applicant is Signal Medical Corporation. The 510(k) number is K203779.

When did Symmetric Total Knee System receive FDA 510(k) clearance?

Symmetric Total Knee System received FDA 510(k) clearance on 2021-06-10, under 510(k) number K203779.

Who is the listed applicant for Symmetric Total Knee System?

The FDA 510(k) record lists Signal Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Symmetric Total Knee System?

The FDA product code for Symmetric Total Knee System is MBH.

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