BowTie™ 骨盆聯合融合系統
K 號：K232149 · 2024-04-20
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器材摘要
BowTie™ SI Joint Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Sail Fusion, LLC. It received FDA 510(k) clearance on 2024-04-20 under 510(k) number K232149. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the BowTie™ SI Joint Fusion System?
BowTie™ SI Joint Fusion System is a medical device that received FDA 510(k) clearance on 2024-04-20. The listed applicant is Sail Fusion, LLC. The 510(k) number is K232149.
When did BowTie™ SI Joint Fusion System receive FDA 510(k) clearance?
BowTie™ SI Joint Fusion System received FDA 510(k) clearance on 2024-04-20, under 510(k) number K232149.
Who is the listed applicant for BowTie™ SI Joint Fusion System?
The FDA 510(k) record lists Sail Fusion, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BowTie™ SI Joint Fusion System?
The FDA product code for BowTie™ SI Joint Fusion System is OUR.
相關臨床試驗
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相關器械（代碼：OUR）
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。
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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