FDA 510(k)

StealthStation椎弓根夹具

K号: K211442 · 2021-07-08

决定日期2021-07-08

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

StealthStation Spinous Process Clamps is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation. It received FDA 510(k) clearance on 2021-07-08 under 510(k) number K211442. 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 StealthStation Spinous Process Clamps?

StealthStation Spinous Process Clamps is a medical device that received FDA 510(k) clearance on 2021-07-08. The listed applicant is Medtronic Navigation. The 510(k) number is K211442.

When did StealthStation Spinous Process Clamps receive FDA 510(k) clearance?

StealthStation Spinous Process Clamps received FDA 510(k) clearance on 2021-07-08, under 510(k) number K211442.

Who is the listed applicant for StealthStation Spinous Process Clamps?

The FDA 510(k) record lists Medtronic Navigation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for StealthStation Spinous Process Clamps?

The FDA product code for StealthStation Spinous Process Clamps is OLO.

列明Medtronic Navigation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。

K250307Visualase V2 MRI引导激光消融系统（9736422）K212397StealthStation S8颅骨v2.0 K201327NavLock Trackers K193579PlasmaBlade X 3.0S LIGHT K182104NavLock Trackers, Robotic Reference Frame K180816Ziehm RFD 3D 跟踪器

查看所有 9 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。