T3 Pro Implants ZimVie Packaging System
K-Number: K251660 · 2025-06-27
ApplicantBiomet 3i, LLC
Decision Date2025-06-27
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
T3 Pro Implants ZimVie Packaging System is a medical device manufactured by Biomet 3i, LLC. It received FDA 510(k) clearance on 2025-06-27 under approval number K251660. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
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. It is manufactured by Biomet 3i, LLC. The 510(k) number is K251660.
When was T3 Pro Implants ZimVie Packaging System approved by the FDA?
T3 Pro Implants ZimVie Packaging System received FDA 510(k) clearance on 2025-06-27, under approval number K251660.
What company makes T3 Pro Implants ZimVie Packaging System?
T3 Pro Implants ZimVie Packaging System is manufactured by Biomet 3i, LLC.
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.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.