FDA 510(k)

FFX 面板固定系統

K 號：K252153 · 2025-10-16

決定日期2025-10-16

產品代碼MRW

決定相當於

器材摘要

FFX Facet Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Sc Medica. It received FDA 510(k) clearance on 2025-10-16 under 510(k) number K252153. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

常見問題

What is the FFX Facet Fixation System?

FFX Facet Fixation System is a medical device that received FDA 510(k) clearance on 2025-10-16. The listed applicant is Sc Medica. The 510(k) number is K252153.

When did FFX Facet Fixation System receive FDA 510(k) clearance?

FFX Facet Fixation System received FDA 510(k) clearance on 2025-10-16, under 510(k) number K252153.

Who is the listed applicant for FFX Facet Fixation System?

The FDA 510(k) record lists Sc Medica as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FFX Facet Fixation System?

The FDA product code for FFX Facet Fixation System is MRW.

其他以 Sc Medica 為申請人之記錄

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。

K250679FFX 面板固定系統 K232468SC Medica FFX

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, LLC K253676CORUS™ 頸後穩定系統 3D (CORUS™ PCSS 3D)Providence Medical Technology, Inc.K253432DiversiVy™ 面板螺釘系統Vy Spine, LLC K251714離子-CSurGenTec, LLC K250679FFX 面板固定系統Sc Medica

官方來源

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