FDA 510(k)

EUROPA® 后路颈椎融合导航仪器

K号: K253444 · 2026-03-18

决定日期2026-03-18

产品代码OLO

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决定实质等同

器械摘要

EUROPA™ Posterior Cervical Fusion Navigated Instruments is the device name listed in this FDA 510(k) record. The listed applicant is MiRus, LLC. It received FDA 510(k) clearance on 2026-03-18 under 510(k) number K253444. 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 EUROPA™ Posterior Cervical Fusion Navigated Instruments?

EUROPA™ Posterior Cervical Fusion Navigated Instruments is a medical device that received FDA 510(k) clearance on 2026-03-18. The listed applicant is MiRus, LLC. The 510(k) number is K253444.

When did EUROPA™ Posterior Cervical Fusion Navigated Instruments receive FDA 510(k) clearance?

EUROPA™ Posterior Cervical Fusion Navigated Instruments received FDA 510(k) clearance on 2026-03-18, under 510(k) number K253444.

Who is the listed applicant for EUROPA™ Posterior Cervical Fusion Navigated Instruments?

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

What is the FDA product code for EUROPA™ Posterior Cervical Fusion Navigated Instruments?

The FDA product code for EUROPA™ Posterior Cervical Fusion Navigated Instruments is OLO.

列明MiRus, LLC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。

K252733ATLAS® 可扩张骨切开楔形系统 K242516EUROPA® 后路颈椎融合系统 K241175MiRus MoRe 腰椎钢板系统 K232348RIGEL™ 3DR 独立前路颈椎椎间融合系统 K232481RIGEL™ 3DR 前路颈椎椎体次全切除系统 K232154MiRus 3DR 侧方腰椎椎间融合系统，带集成钢板固定

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官方来源

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