FDA 510(k)

Firebird SI 导航系统

K号: K252088 · 2025-10-31

决定日期2025-10-31

产品代码OLO

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决定实质等同

器械摘要

Firebird SI Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix US, LLC. It received FDA 510(k) clearance on 2025-10-31 under 510(k) number K252088. 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 Firebird SI Navigation System?

Firebird SI Navigation System is a medical device that received FDA 510(k) clearance on 2025-10-31. The listed applicant is Orthofix US, LLC. The 510(k) number is K252088.

When did Firebird SI Navigation System receive FDA 510(k) clearance?

Firebird SI Navigation System received FDA 510(k) clearance on 2025-10-31, under 510(k) number K252088.

Who is the listed applicant for Firebird SI Navigation System?

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

What is the FDA product code for Firebird SI Navigation System?

The FDA product code for Firebird SI Navigation System is OLO.

列明Orthofix US, 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。

K230252OFIX MIS App K2117123°颈椎前路钢板系统，Reliant颈椎前路钢板系统，Unity腰骶部固定系统，Hallmark前路钢板系统，NewBridge椎板成形术固定系统，CETRA颈椎前路钢板系统 K213951FORZA XP 可扩张间隔系统

官方来源

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