FDA 510(k)

QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments

Número K: K231850 · 2024-03-14

Data da decisão2024-03-14

Código do produtoNKG

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments 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 2024-03-14 under 510(k) number K231850. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments?

QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments is a medical device that received FDA 510(k) clearance on 2024-03-14. The listed applicant is Globus Medical, Inc.. The 510(k) number is K231850.

When did QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments receive FDA 510(k) clearance?

QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments received FDA 510(k) clearance on 2024-03-14, under 510(k) number K231850.

Who is the listed applicant for QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments?

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 QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments?

The FDA product code for QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments is NKG.

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Fonte oficial

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