富麗金屬可鎖定內骨髓釘系統
K 號：K253155 · 2026-06-17
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器材摘要
Fule Metallic Lockable Intramedullary Nail Systems is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Fule Science & Technology Development Co., Ltd.. It received FDA 510(k) clearance on 2026-06-17 under 510(k) number K253155. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Fule Metallic Lockable Intramedullary Nail Systems?
Fule Metallic Lockable Intramedullary Nail Systems is a medical device that received FDA 510(k) clearance on 2026-06-17. The listed applicant is Beijing Fule Science & Technology Development Co., Ltd.. The 510(k) number is K253155.
When did Fule Metallic Lockable Intramedullary Nail Systems receive FDA 510(k) clearance?
Fule Metallic Lockable Intramedullary Nail Systems received FDA 510(k) clearance on 2026-06-17, under 510(k) number K253155.
Who is the listed applicant for Fule Metallic Lockable Intramedullary Nail Systems?
FDA 510(k) 記錄將北京富麗科學技術開發有限公司列為申請人。這並不單獨確立設備製造商的身份。
What is the FDA product code for Fule Metallic Lockable Intramedullary Nail Systems?
The FDA product code for Fule Metallic Lockable Intramedullary Nail Systems is HSB.
相關臨床試驗
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其他以 Beijing Fule Science & Technology Development Co., Ltd. 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：HSB）
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。
K261345兒童釘針平台 髋骨OrthoPediatrics Corp.K261481Pangea 髋骨重建系統Stryker GmbHK253080AND 医療股骨釘系統 (PFNA01); AND 医療股骨釘系統 (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max 系統及 Precice™ 腳踝挽救系統NuVasive Specialized OrthopedicsK253046HERA 開合式硬脊釘系統ZheJiang Decans Medical Devices Co., Ltd.K260146FITBONE® 転移與延長系統Orthofix Srl
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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