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FDA 510(k)

MIS C1 窄平台錐形連接植入系統,MIS C1 寬平台錐形連接基座

K 號:K172505 · 2017-12-28

決定日期2017-12-28
產品代碼DZE
諮詢委員會DE
決定相當於

器材摘要

MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Mis Implants Technologies , Ltd.. It received FDA 510(k) clearance on 2017-12-28 under 510(k) number K172505. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments?

MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments is a medical device that received FDA 510(k) clearance on 2017-12-28. The listed applicant is Mis Implants Technologies , Ltd.. The 510(k) number is K172505.

When did MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments receive FDA 510(k) clearance?

MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments received FDA 510(k) clearance on 2017-12-28, under 510(k) number K172505.

Who is the listed applicant for MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments?

The FDA 510(k) record lists Mis Implants Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments?

The FDA product code for MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments is DZE.

相關臨床試驗

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其他以 Mis Implants Technologies , 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:DZE)

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

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