FDA 510(k)

Catalyst OrthoScience CSR Shoulder System

Número K: K191811 · 2019-09-11

Data da decisão2019-09-11

Código do produtoKWT

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Catalyst OrthoScience CSR Shoulder System 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 2019-09-11 under 510(k) number K191811. 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 OrthoScience CSR Shoulder System?

Catalyst OrthoScience CSR Shoulder System is a medical device that received FDA 510(k) clearance on 2019-09-11. The listed applicant is Catalyst Orthoscience, Inc.. The 510(k) number is K191811.

When did Catalyst OrthoScience CSR Shoulder System receive FDA 510(k) clearance?

Catalyst OrthoScience CSR Shoulder System received FDA 510(k) clearance on 2019-09-11, under 510(k) number K191811.

Who is the listed applicant for Catalyst OrthoScience CSR Shoulder System?

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 OrthoScience CSR Shoulder System?

The FDA product code for Catalyst OrthoScience CSR Shoulder System is KWT.

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Outros registros que listam Catalyst Orthoscience, Inc. como candidato(a)

K252418Catalyst F1x Shoulder System K234105Catalyst F1x Shoulder System K232583Catalyst R1 Reverse Shoulder System K223655Catalyst R1 Reverse Shoulder System K222317Catalyst EA Convertible Stemmed Shoulder K213349Catalyst R1 Reverse Shoulder System

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Dispositivos Relacionados (Código: KWT)

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Fonte oficial

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