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FDA 510(k)

3.0 Dynamic TiBase

K-Number: K162021 · 2018-05-04

Decision Date2018-05-04
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

3.0 Dynamic TiBase is a medical device manufactured by Talladium Espana, SL. It received FDA 510(k) clearance on 2018-05-04 under approval number K162021. 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 3.0 Dynamic TiBase?

3.0 Dynamic TiBase is a medical device that received FDA 510(k) clearance on 2018-05-04. It is manufactured by Talladium Espana, SL. The 510(k) number is K162021.

When was 3.0 Dynamic TiBase approved by the FDA?

3.0 Dynamic TiBase received FDA 510(k) clearance on 2018-05-04, under approval number K162021.

What company makes 3.0 Dynamic TiBase?

3.0 Dynamic TiBase is manufactured by Talladium Espana, SL.

What is the FDA product code for 3.0 Dynamic TiBase?

The FDA product code for 3.0 Dynamic TiBase is NHA.

Other Devices by Talladium Espana, SL

Related Devices (Code: NHA)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.