FDA 510(k)

Intellijoint® 导航系统

K号: K191507 · 2019-10-01

决定日期2019-10-01

产品代码OLO

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决定实质等同

器械摘要

Intellijoint® Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Intellijoint Surgical, Inc.. It received FDA 510(k) clearance on 2019-10-01 under 510(k) number K191507. 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 Intellijoint® Navigation System?

Intellijoint® Navigation System is a medical device that received FDA 510(k) clearance on 2019-10-01. The listed applicant is Intellijoint Surgical, Inc.. The 510(k) number is K191507.

When did Intellijoint® Navigation System receive FDA 510(k) clearance?

Intellijoint® Navigation System received FDA 510(k) clearance on 2019-10-01, under 510(k) number K191507.

Who is the listed applicant for Intellijoint® Navigation System?

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

What is the FDA product code for Intellijoint® Navigation System?

The FDA product code for Intellijoint® Navigation System is OLO.

列明Intellijoint Surgical, 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。

K211876Intellijoint VIEW K172849Intellijoint HIP 系统 K171525Intellijoint HIP 系统（车用），Intellijoint HIP 系统（便携式），Intellijoint HIP 仪器托盘 K162364Intellijoint HIP 2A 系统

官方来源

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