AERO MIS 閃椎融合系統
K 號：K243865 · 2025-03-24
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器材摘要
AERO MIS Facet Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Aurora Spine. It received FDA 510(k) clearance on 2025-03-24 under 510(k) number K243865. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.
常見問題
What is the AERO MIS Facet Fusion System?
AERO MIS Facet Fusion System is a medical device that received FDA 510(k) clearance on 2025-03-24. The listed applicant is Aurora Spine. The 510(k) number is K243865.
When did AERO MIS Facet Fusion System receive FDA 510(k) clearance?
AERO MIS Facet Fusion System received FDA 510(k) clearance on 2025-03-24, under 510(k) number K243865.
Who is the listed applicant for AERO MIS Facet Fusion System?
The FDA 510(k) record lists Aurora Spine as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AERO MIS Facet Fusion System?
The FDA product code for AERO MIS Facet Fusion System is MRW.
相關臨床試驗
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。
相關器械（代碼：MRW）
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。
K262618Arthrex 腰椎壓縮 FT 螺釘Arthrex, Inc.K261209離子-L
(注意：原文中 "device_name" 和 "medical-device regulatory text" 沒有提供完整的內容，因此只能根據 "Ion-L" 進行翻譯。如果需要完整的翻譯，請提供完整的文本。)SurGenTec, LLCK253676CORUS™ 頸後穩定系統 3D (CORUS™ PCSS 3D)Providence Medical Technology, Inc.K253432DiversiVy™ 面板螺釘系統Vy Spine, LLCK251714離子-CSurGenTec, LLCK250679FFX 面板固定系統Sc Medica
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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