CoLink NeoFuse MIS 鍵合系統（見附檔零組件清單）
K 號：K241387 · 2024-08-13
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器材摘要
CoLink NeoFuse MIS Plating System (see attached parts list) is the device name listed in this FDA 510(k) record. The listed applicant is In2bones USA. It received FDA 510(k) clearance on 2024-08-13 under 510(k) number K241387. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the CoLink NeoFuse MIS Plating System (see attached parts list)?
CoLink NeoFuse MIS Plating System (see attached parts list) is a medical device that received FDA 510(k) clearance on 2024-08-13. The listed applicant is In2bones USA. The 510(k) number is K241387.
When did CoLink NeoFuse MIS Plating System (see attached parts list) receive FDA 510(k) clearance?
CoLink NeoFuse MIS Plating System (see attached parts list) received FDA 510(k) clearance on 2024-08-13, under 510(k) number K241387.
Who is the listed applicant for CoLink NeoFuse MIS Plating System (see attached parts list)?
The FDA 510(k) record lists In2bones USA as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CoLink NeoFuse MIS Plating System (see attached parts list)?
The FDA product code for CoLink NeoFuse MIS Plating System (see attached parts list) is HRS.
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。
相關器械（代碼：HRS）
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。
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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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