FDA 510(k)

Zavation 导航仪器系统

K号: K223808 · 2023-07-12

决定日期2023-07-12

产品代码OLO

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决定实质等同

器械摘要

Zavation Navigation Instrument System is the device name listed in this FDA 510(k) record. The listed applicant is Zavation Medical Products, LLC. It received FDA 510(k) clearance on 2023-07-12 under 510(k) number K223808. 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 Zavation Navigation Instrument System?

Zavation Navigation Instrument System is a medical device that received FDA 510(k) clearance on 2023-07-12. The listed applicant is Zavation Medical Products, LLC. The 510(k) number is K223808.

When did Zavation Navigation Instrument System receive FDA 510(k) clearance?

Zavation Navigation Instrument System received FDA 510(k) clearance on 2023-07-12, under 510(k) number K223808.

Who is the listed applicant for Zavation Navigation Instrument System?

FDA 510(k)记录显示Zavation Medical Products, LLC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 Zavation Navigation Instrument System?

The FDA product code for Zavation Navigation Instrument System is OLO.

列明Zavation Medical Products, 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。

K253943老虎2系统 K243908老虎2系统 K233509Zavation IBF系统，Zavation Varisync板系统及Varisync间隔器系统，LABYRINTH系统，Zavation ALIF系统 K231811Zavation 连接系统 K230731Zavation ALIF系统 K221726Uni-FuZe-C 骨条

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官方来源

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