FDA 510(k)

Intellijoint HIP 2A 系统

K号: K162364 · 2017-03-02

决定日期2017-03-02

产品代码OLO

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决定实质等同

器械摘要

Intellijoint HIP Generation 2A 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 2017-03-02 under 510(k) number K162364. 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 HIP Generation 2A System?

Intellijoint HIP Generation 2A System is a medical device that received FDA 510(k) clearance on 2017-03-02. The listed applicant is Intellijoint Surgical, Inc.. The 510(k) number is K162364.

When did Intellijoint HIP Generation 2A System receive FDA 510(k) clearance?

Intellijoint HIP Generation 2A System received FDA 510(k) clearance on 2017-03-02, under 510(k) number K162364.

Who is the listed applicant for Intellijoint HIP Generation 2A 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 HIP Generation 2A System?

The FDA product code for Intellijoint HIP Generation 2A 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 K191507Intellijoint® 导航系统 K172849Intellijoint HIP 系统 K171525Intellijoint HIP 系统（车用），Intellijoint HIP 系统（便携式），Intellijoint HIP 仪器托盘

官方来源

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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。