FDA 510(k)

Remex脊柱外科导航仪器

K号: K243560 · 2024-12-13

决定日期2024-12-13

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

Remex Spine Surgery Navigation Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Remex Medical Corp.. It received FDA 510(k) clearance on 2024-12-13 under 510(k) number K243560. 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 Remex Spine Surgery Navigation Instrument?

Remex Spine Surgery Navigation Instrument is a medical device that received FDA 510(k) clearance on 2024-12-13. The listed applicant is Remex Medical Corp.. The 510(k) number is K243560.

When did Remex Spine Surgery Navigation Instrument receive FDA 510(k) clearance?

Remex Spine Surgery Navigation Instrument received FDA 510(k) clearance on 2024-12-13, under 510(k) number K243560.

Who is the listed applicant for Remex Spine Surgery Navigation Instrument?

FDA 510(k)记录将Remex Medical Corp.列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Remex Spine Surgery Navigation Instrument?

The FDA product code for Remex Spine Surgery Navigation Instrument is OLO.

列明Remex Medical Corp.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。

K262506Remex脊柱外科导航 - 通用工具 K251315Anatase 脊柱手术导航系统及Remex 脊柱手术导航系统II K241625Anatase Navi 可用仪器 K233513Remex脊柱外科导航系统II K230783Anatase 脊柱手术导航系统

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。