FDA 510(k)

TiLink-L 导航仪器

K号: K253604 · 2026-03-20

决定日期2026-03-20

产品代码OLO

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决定实质等同

器械摘要

TiLink-L Navigation Instruments is the device name listed in this FDA 510(k) record. The listed applicant is SurGenTec, LLC. It received FDA 510(k) clearance on 2026-03-20 under 510(k) number K253604. 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 TiLink-L Navigation Instruments?

TiLink-L Navigation Instruments is a medical device that received FDA 510(k) clearance on 2026-03-20. The listed applicant is SurGenTec, LLC. The 510(k) number is K253604.

When did TiLink-L Navigation Instruments receive FDA 510(k) clearance?

TiLink-L Navigation Instruments received FDA 510(k) clearance on 2026-03-20, under 510(k) number K253604.

Who is the listed applicant for TiLink-L Navigation Instruments?

FDA 510(k)记录中列出SurGenTec, LLC为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for TiLink-L Navigation Instruments?

The FDA product code for TiLink-L Navigation Instruments is OLO.

列明SurGenTec, LLC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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官方来源

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