FDA 510(k)

Spine Wave 导航工具

K号: K192526 · 2019-10-10

决定日期2019-10-10

产品代码OLO

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决定实质等同

器械摘要

Spine Wave Navigated Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Spine Wave, Inc.. It received FDA 510(k) clearance on 2019-10-10 under 510(k) number K192526. 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 Spine Wave Navigated Instruments?

Spine Wave Navigated Instruments is a medical device that received FDA 510(k) clearance on 2019-10-10. The listed applicant is Spine Wave, Inc.. The 510(k) number is K192526.

When did Spine Wave Navigated Instruments receive FDA 510(k) clearance?

Spine Wave Navigated Instruments received FDA 510(k) clearance on 2019-10-10, under 510(k) number K192526.

Who is the listed applicant for Spine Wave Navigated Instruments?

The FDA 510(k) record lists Spine Wave, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Spine Wave Navigated Instruments?

The FDA product code for Spine Wave Navigated Instruments is OLO.

列明Spine Wave, Inc.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。

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