T3 Pro 假體
K 號：K213672 · 2022-03-28
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器材摘要
T3 Pro Implants is the device name listed in this FDA 510(k) record. The listed applicant is Biomet 3i, LLC. It received FDA 510(k) clearance on 2022-03-28 under 510(k) number K213672. 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 T3 Pro Implants?
T3 Pro Implants is a medical device that received FDA 510(k) clearance on 2022-03-28. The listed applicant is Biomet 3i, LLC. The 510(k) number is K213672.
When did T3 Pro Implants receive FDA 510(k) clearance?
T3 Pro Implants received FDA 510(k) clearance on 2022-03-28, under 510(k) number K213672.
Who is the listed applicant for T3 Pro Implants?
The FDA 510(k) record lists Biomet 3i, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for T3 Pro Implants?
The FDA product code for T3 Pro Implants is DZE.
相關臨床試驗
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其他以 Biomet 3i, LLC 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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