FDA 510(k)

iGPS 导航仪器

K号: K251780 · 2025-09-15

决定日期2025-09-15

产品代码OLO

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决定实质等同

器械摘要

iGPS Navigation Instruments is the device name listed in this FDA 510(k) record. The listed applicant is SI-BONE, Inc.. It received FDA 510(k) clearance on 2025-09-15 under 510(k) number K251780. 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 iGPS Navigation Instruments?

iGPS Navigation Instruments is a medical device that received FDA 510(k) clearance on 2025-09-15. The listed applicant is SI-BONE, Inc.. The 510(k) number is K251780.

When did iGPS Navigation Instruments receive FDA 510(k) clearance?

iGPS Navigation Instruments received FDA 510(k) clearance on 2025-09-15, under 510(k) number K251780.

Who is the listed applicant for iGPS Navigation Instruments?

FDA 510(k)记录中列出SI-BONE，Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for iGPS Navigation Instruments?

The FDA product code for iGPS Navigation Instruments is OLO.

列明SI-BONE, 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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