ALLY® 閃椎螺釘
K 號：K163374 · 2017-02-16
廣告
器材摘要
ALLY™ Facet Screws 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 2017-02-16 under 510(k) number K163374. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.
常見問題
What is the ALLY™ Facet Screws?
ALLY™ Facet Screws is a medical device that received FDA 510(k) clearance on 2017-02-16. The listed applicant is Providence Medical Technology, Inc.. The 510(k) number is K163374.
When did ALLY™ Facet Screws receive FDA 510(k) clearance?
ALLY™ Facet Screws received FDA 510(k) clearance on 2017-02-16, under 510(k) number K163374.
Who is the listed applicant for ALLY™ Facet Screws?
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 ALLY™ Facet Screws?
The FDA product code for ALLY™ Facet Screws 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。
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。
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。
廣告