Inversa 假體
K 號：K181850 · 2018-11-14
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器材摘要
Inversa Implants is the device name listed in this FDA 510(k) record. The listed applicant is Southern Implants (Pty), Ltd.. It received FDA 510(k) clearance on 2018-11-14 under 510(k) number K181850. 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 Inversa Implants?
Inversa Implants is a medical device that received FDA 510(k) clearance on 2018-11-14. The listed applicant is Southern Implants (Pty), Ltd.. The 510(k) number is K181850.
When did Inversa Implants receive FDA 510(k) clearance?
Inversa Implants received FDA 510(k) clearance on 2018-11-14, under 510(k) number K181850.
Who is the listed applicant for Inversa Implants?
The FDA 510(k) record lists Southern Implants (Pty), Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Inversa Implants?
The FDA product code for Inversa Implants is DZE.
相關臨床試驗
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其他以 Southern Implants (Pty), 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
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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