FDA 510(k)

T3 Pro Implants– ZimVie Packaging System

K号: K251660 · 2025-06-27

决定日期2025-06-27

产品代码DZE

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决定实质等同

器械摘要

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.

常见问题

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.

列明Biomet 3i, LLC为申报人的其他记录

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