FDA 510(k)

QUARTEX® 頸胸椎脊柱系統 ExcelsiusGPS® 工具

K 號：K231850 · 2024-03-14

決定日期2024-03-14

產品代碼NKG

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器材摘要

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.

常見問題

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?

FDA 510(k) 記錄將 Globus Medical, Inc. 列為申請人。這並不單獨確立設備製造商。

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.

其他以 Globus Medical, Inc. 為申請人之記錄

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相關器械（代碼：NKG）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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