中樞骨內髓骨折固定（IFF）系統
K 號：K250316 · 2025-10-29
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器材摘要
Meduloc Intramedullary Fracture Fixation (IFF) System is the device name listed in this FDA 510(k) record. The listed applicant is Meduloc, LLC. It received FDA 510(k) clearance on 2025-10-29 under 510(k) number K250316. The device is classified under product code JDW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Meduloc Intramedullary Fracture Fixation (IFF) System?
Meduloc Intramedullary Fracture Fixation (IFF) System is a medical device that received FDA 510(k) clearance on 2025-10-29. The listed applicant is Meduloc, LLC. The 510(k) number is K250316.
When did Meduloc Intramedullary Fracture Fixation (IFF) System receive FDA 510(k) clearance?
Meduloc Intramedullary Fracture Fixation (IFF) System received FDA 510(k) clearance on 2025-10-29, under 510(k) number K250316.
Who is the listed applicant for Meduloc Intramedullary Fracture Fixation (IFF) System?
The FDA 510(k) record lists Meduloc, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Meduloc Intramedullary Fracture Fixation (IFF) System?
The FDA product code for Meduloc Intramedullary Fracture Fixation (IFF) System is JDW.
相關臨床試驗
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相關器械（代碼：JDW）
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。
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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