FDA 510(k)

PMT後頸穩定系統（PCSS）

K 號：K241035 · 2024-06-25

決定日期2024-06-25

產品代碼MRW

決定相當於

器材摘要

PMT Posterior Cervical Stabilization System (PCSS) 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 2024-06-25 under 510(k) number K241035. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

常見問題

What is the PMT Posterior Cervical Stabilization System (PCSS)?

PMT Posterior Cervical Stabilization System (PCSS) is a medical device that received FDA 510(k) clearance on 2024-06-25. The listed applicant is Providence Medical Technology, Inc.. The 510(k) number is K241035.

When did PMT Posterior Cervical Stabilization System (PCSS) receive FDA 510(k) clearance?

PMT Posterior Cervical Stabilization System (PCSS) received FDA 510(k) clearance on 2024-06-25, under 510(k) number K241035.

Who is the listed applicant for PMT Posterior Cervical Stabilization System (PCSS)?

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 PMT Posterior Cervical Stabilization System (PCSS)?

The FDA product code for PMT Posterior Cervical Stabilization System (PCSS) 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 K251885CAVUX 閃骨固定系統（CAVUX FFS）及 CORUS-LX 假體 K240625CORUS導航存取系統

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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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