融合纖維固定釘
K 號：K252961 · 2026-03-18
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器材摘要
Fusion FibFix Nail is the device name listed in this FDA 510(k) record. The listed applicant is Fusion Orthopedics USA, LLC. It received FDA 510(k) clearance on 2026-03-18 under 510(k) number K252961. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Fusion FibFix Nail?
Fusion FibFix Nail is a medical device that received FDA 510(k) clearance on 2026-03-18. The listed applicant is Fusion Orthopedics USA, LLC. The 510(k) number is K252961.
When did Fusion FibFix Nail receive FDA 510(k) clearance?
Fusion FibFix Nail received FDA 510(k) clearance on 2026-03-18, under 510(k) number K252961.
Who is the listed applicant for Fusion FibFix Nail?
The FDA 510(k) record lists Fusion Orthopedics USA, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Fusion FibFix Nail?
The FDA product code for Fusion FibFix Nail is HSB.
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相關器械（代碼：HSB）
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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