FDA 510(k)

离子-C导航仪器

K号: K260329 · 2026-05-22

决定日期2026-05-22

产品代码OLO

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Ion-C 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 2026-05-22 under 510(k) number K260329. 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 Ion-C Navigation Instruments?

Ion-C Navigation Instruments is a medical device that received FDA 510(k) clearance on 2026-05-22. The listed applicant is SurGenTec, LLC. The 510(k) number is K260329.

When did Ion-C Navigation Instruments receive FDA 510(k) clearance?

Ion-C Navigation Instruments received FDA 510(k) clearance on 2026-05-22, under 510(k) number K260329.

Who is the listed applicant for Ion-C 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 Ion-C Navigation Instruments?

The FDA product code for Ion-C 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。

K252995杜拉盾设备套件 K262581GraftGun® 全能移植物输送系统（GDS®）K261381TiLink-L™ 髋关节融合系统 K262121离子-L 导航仪器 K261209离子-L K253604TiLink-L 导航仪器

查看所有 29 个设备 →

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。