BellaTek Bars
K-Number: K241032 · 2024-07-15
ApplicantBiomet 3i, LLC
Decision Date2024-07-15
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
BellaTek Bars is a medical device manufactured by Biomet 3i, LLC. It received FDA 510(k) clearance on 2024-07-15 under approval number K241032. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BellaTek Bars?
BellaTek Bars is a medical device that received FDA 510(k) clearance on 2024-07-15. It is manufactured by Biomet 3i, LLC. The 510(k) number is K241032.
When was BellaTek Bars approved by the FDA?
BellaTek Bars received FDA 510(k) clearance on 2024-07-15, under approval number K241032.
What company makes BellaTek Bars?
BellaTek Bars is manufactured by Biomet 3i, LLC.
What is the FDA product code for BellaTek Bars?
The FDA product code for BellaTek Bars is NHA.
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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.