FDA 510(k)

T3 Pro 假體 – ZimVie 包裝系統

K 號：K251660 · 2025-06-27

決定日期2025-06-27

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

T3 Pro Implants– ZimVie Packaging System 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 2025-06-27 under 510(k) number K251660. 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– ZimVie Packaging System?

T3 Pro Implants– ZimVie Packaging System is a medical device that received FDA 510(k) clearance on 2025-06-27. The listed applicant is Biomet 3i, LLC. The 510(k) number is K251660.

When did T3 Pro Implants– ZimVie Packaging System receive FDA 510(k) clearance?

T3 Pro Implants– ZimVie Packaging System received FDA 510(k) clearance on 2025-06-27, under 510(k) number K251660.

Who is the listed applicant for T3 Pro Implants– ZimVie Packaging System?

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– ZimVie Packaging System?

The FDA product code for T3 Pro Implants– ZimVie Packaging System is DZE.

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。

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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。

K261392三活牙植體系統Paragon Implant Mfg., LLC K260463ZEROS 齿科植體系統Zeros Co., Ltd.K251188UNIQA® 齿科植體系統Uniqa Dental, Ltd.K251232MegaGen 遺傳子顎骨牙植體系統Megagen Implant Co., Ltd.K250806牙齒植體系統A.B. Dental Devices , Ltd.K260006INOS系統Inosys, Inc.

官方來源

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