FDA 510(k)

CAVUX 閃骨固定系統（CAVUX FFS）及 CORUS-LX 假體

K 號：K251885 · 2025-07-10

決定日期2025-07-10

產品代碼MRW

決定相當於

器材摘要

CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant is the device name listed in this FDA 510(k) record. The listed applicant is Providence Medical Technology, Inc.. It received FDA 510(k) clearance on 2025-07-10 under 510(k) number K251885. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

常見問題

What is the CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant?

CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant is a medical device that received FDA 510(k) clearance on 2025-07-10. The listed applicant is Providence Medical Technology, Inc.. The 510(k) number is K251885.

When did CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant receive FDA 510(k) clearance?

CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant received FDA 510(k) clearance on 2025-07-10, under 510(k) number K251885.

Who is the listed applicant for CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant?

The FDA 510(k) record lists Providence Medical Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant?

The FDA product code for CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant is MRW.

其他以 Providence Medical Technology, Inc. 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。

K261665CORUS™導航系統-GN K253676CORUS™ 頸後穩定系統 3D (CORUS™ PCSS 3D)K253190CORUS-LX 假體 K251060CORUS™導航系統-GX K241035PMT後頸穩定系統（PCSS）K240625CORUS導航存取系統

查看所有 19 項裝置 →

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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