Cortium®系统导航模块
K号: K252087 · 2026-02-03
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决定日期2026-02-03
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
Navigation Module of the Cortium® System is the device name listed in this FDA 510(k) record. The listed applicant is Ulrich Medical USA, Inc.. It received FDA 510(k) clearance on 2026-02-03 under 510(k) number K252087. 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 Navigation Module of the Cortium® System?
Navigation Module of the Cortium® System is a medical device that received FDA 510(k) clearance on 2026-02-03. The listed applicant is Ulrich Medical USA, Inc.. The 510(k) number is K252087.
When did Navigation Module of the Cortium® System receive FDA 510(k) clearance?
Navigation Module of the Cortium® System received FDA 510(k) clearance on 2026-02-03, under 510(k) number K252087.
Who is the listed applicant for Navigation Module of the Cortium® System?
The FDA 510(k) record lists Ulrich Medical USA, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Navigation Module of the Cortium® System?
The FDA product code for Navigation Module of the Cortium® System is OLO.
相关临床试验
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列明Ulrich Medical USA, 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。
相关器械（代码：OLO）
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。
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。
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