FDA 510(k)

COSINE™ Spacer

Número K: K234035 · 2024-09-06

Data da decisão2024-09-06

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

COSINE™ Spacer is the device name listed in this FDA 510(k) record. The listed applicant is Globus Medical, Inc.. It received FDA 510(k) clearance on 2024-09-06 under 510(k) number K234035. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the COSINE™ Spacer?

COSINE™ Spacer is a medical device that received FDA 510(k) clearance on 2024-09-06. The listed applicant is Globus Medical, Inc.. The 510(k) number is K234035.

When did COSINE™ Spacer receive FDA 510(k) clearance?

COSINE™ Spacer received FDA 510(k) clearance on 2024-09-06, under 510(k) number K234035.

Who is the listed applicant for COSINE™ Spacer?

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

What is the FDA product code for COSINE™ Spacer?

The FDA product code for COSINE™ Spacer is MAX.

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Fonte oficial

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