FDA 510(k)

ExcelsiusGPS® 仪器

K号: K243671 · 2024-12-20

决定日期2024-12-20

产品代码OLO

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决定实质等同

器械摘要

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 2024-12-20 under 510(k) number K243671. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ExcelsiusGPS® Instruments?

ExcelsiusGPS® Instruments is a medical device that received FDA 510(k) clearance on 2024-12-20. The listed applicant is Globus Medical, Inc.. The 510(k) number is K243671.

When did ExcelsiusGPS® Instruments receive FDA 510(k) clearance?

ExcelsiusGPS® Instruments received FDA 510(k) clearance on 2024-12-20, under 510(k) number K243671.

Who is the listed applicant for ExcelsiusGPS® Instruments?

FDA 510(k)记录中列出Globus Medical, Inc.为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for ExcelsiusGPS® Instruments?

The FDA product code for ExcelsiusGPS® Instruments is OLO.

列明Globus Medical, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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