FDA 510(k)

Catalyst CSR Press-Fit Humeral Components

Número K: K182500 · 2019-01-11

Data da decisão2019-01-11

Código do produtoKWT

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Catalyst CSR Press-Fit Humeral Components is the device name listed in this FDA 510(k) record. The listed applicant is Catalyst Orthoscience, Inc.. It received FDA 510(k) clearance on 2019-01-11 under 510(k) number K182500. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Catalyst CSR Press-Fit Humeral Components?

Catalyst CSR Press-Fit Humeral Components is a medical device that received FDA 510(k) clearance on 2019-01-11. The listed applicant is Catalyst Orthoscience, Inc.. The 510(k) number is K182500.

When did Catalyst CSR Press-Fit Humeral Components receive FDA 510(k) clearance?

Catalyst CSR Press-Fit Humeral Components received FDA 510(k) clearance on 2019-01-11, under 510(k) number K182500.

Who is the listed applicant for Catalyst CSR Press-Fit Humeral Components?

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

What is the FDA product code for Catalyst CSR Press-Fit Humeral Components?

The FDA product code for Catalyst CSR Press-Fit Humeral Components is KWT.

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Fonte oficial

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