FDA 510(k)

火鳳凰SI導航系統

K 號：K252088 · 2025-10-31

決定日期2025-10-31

產品代碼OLO

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

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.

常見問題

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.

其他以 Orthofix US, LLC 為申請人之記錄

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相關器械（代碼：OLO）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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