FDA 510(k)

OrthoGrid Hip AI® 4.0

K号: K260077 · 2026-05-29

决定日期2026-05-29

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

OrthoGrid Hip AI® 4.0 is the device name listed in this FDA 510(k) record. The listed applicant is OrthoGrid Systems, Inc.. It received FDA 510(k) clearance on 2026-05-29 under 510(k) number K260077. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the OrthoGrid Hip AI® 4.0?

OrthoGrid Hip AI® 4.0 is a medical device that received FDA 510(k) clearance on 2026-05-29. The listed applicant is OrthoGrid Systems, Inc.. The 510(k) number is K260077.

When did OrthoGrid Hip AI® 4.0 receive FDA 510(k) clearance?

OrthoGrid Hip AI® 4.0 received FDA 510(k) clearance on 2026-05-29, under 510(k) number K260077.

Who is the listed applicant for OrthoGrid Hip AI® 4.0?

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

What is the FDA product code for OrthoGrid Hip AI® 4.0?

The FDA product code for OrthoGrid Hip AI® 4.0 is QIH.

列明OrthoGrid Systems, 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。

K210136PhantomMSK髋关节 K192279PhantomMSK创伤 K182332PhantomMSK

官方来源

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