FDA 510(k)

X-Guide® 手术导航系统

K号: K200662 · 2020-05-21

决定日期2020-05-21

产品代码PLV

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决定实质等同

器械摘要

X-Guide® Surgical Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is X-Nav Technologies, LLC. It received FDA 510(k) clearance on 2020-05-21 under 510(k) number K200662. The device is classified under product code PLV. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the X-Guide® Surgical Navigation System?

X-Guide® Surgical Navigation System is a medical device that received FDA 510(k) clearance on 2020-05-21. The listed applicant is X-Nav Technologies, LLC. The 510(k) number is K200662.

When did X-Guide® Surgical Navigation System receive FDA 510(k) clearance?

X-Guide® Surgical Navigation System received FDA 510(k) clearance on 2020-05-21, under 510(k) number K200662.

Who is the listed applicant for X-Guide® Surgical Navigation System?

FDA 510(k)记录中列出了X-Nav Technologies, LLC作为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for X-Guide® Surgical Navigation System?

The FDA product code for X-Guide® Surgical Navigation System is PLV.

列明X-Nav Technologies, 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。

K253954X-Guide 手术导航系统 K232148X-Guide 手术导航系统 K211701X-Guide® 手术导航系统 K192579X-Guide 手术导航系统

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。