FDA 510(k)

Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161

Número K: K201072 · 2020-12-02

Data da decisão2020-12-02

Código do produtoKYI

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 is the device name listed in this FDA 510(k) record. The listed applicant is Ensemble Orthopedics, LLC. It received FDA 510(k) clearance on 2020-12-02 under 510(k) number K201072. The device is classified under product code KYI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161?

Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 is a medical device that received FDA 510(k) clearance on 2020-12-02. The listed applicant is Ensemble Orthopedics, LLC. The 510(k) number is K201072.

When did Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 receive FDA 510(k) clearance?

Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 received FDA 510(k) clearance on 2020-12-02, under 510(k) number K201072.

Who is the listed applicant for Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161?

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

What is the FDA product code for Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161?

The FDA product code for Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 is KYI.

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Fonte oficial

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