FDA 510(k)

VERTICALE® 导航仪器

K号: K223649 · 2022-12-22

决定日期2022-12-22

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

VERTICALE® Navigation Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Silony Medical GmbH. It received FDA 510(k) clearance on 2022-12-22 under 510(k) number K223649. 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 VERTICALE® Navigation Instruments?

VERTICALE® Navigation Instruments is a medical device that received FDA 510(k) clearance on 2022-12-22. The listed applicant is Silony Medical GmbH. The 510(k) number is K223649.

When did VERTICALE® Navigation Instruments receive FDA 510(k) clearance?

VERTICALE® Navigation Instruments received FDA 510(k) clearance on 2022-12-22, under 510(k) number K223649.

Who is the listed applicant for VERTICALE® Navigation Instruments?

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

What is the FDA product code for VERTICALE® Navigation Instruments?

The FDA product code for VERTICALE® Navigation Instruments is OLO.

列明Silony Medical GmbH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。

K253921VERTICALE® 导航仪器 K254148垂直GPS仪器 K223806VERTICALE® 三角固定系统 K212007垂直导航仪器 K192013VERTICALE® 颈椎系统 K190680FAVO S-TLIF

查看所有 13 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。