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FDA 510(k)

JJ植入系統

K 號:K190552 · 2019-12-06

申請人Jj Implants
決定日期2019-12-06
產品代碼DZE
諮詢委員會DE
決定相當於

器材摘要

JJ Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Jj Implants. It received FDA 510(k) clearance on 2019-12-06 under 510(k) number K190552. 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 JJ Implant System?

JJ Implant System is a medical device that received FDA 510(k) clearance on 2019-12-06. The listed applicant is Jj Implants. The 510(k) number is K190552.

When did JJ Implant System receive FDA 510(k) clearance?

JJ Implant System received FDA 510(k) clearance on 2019-12-06, under 510(k) number K190552.

Who is the listed applicant for JJ Implant System?

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

What is the FDA product code for JJ Implant System?

The FDA product code for JJ Implant System is DZE.

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: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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