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FDA 510(k)

EUROSCREW NG; EUROSCREW TCP NG

K-Number: K230394 · 2023-05-12

ApplicantTeknimed
Decision Date2023-05-12
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EUROSCREW NG; EUROSCREW TCP NG is a medical device manufactured by Teknimed. It received FDA 510(k) clearance on 2023-05-12 under approval number K230394. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EUROSCREW NG; EUROSCREW TCP NG?

EUROSCREW NG; EUROSCREW TCP NG is a medical device that received FDA 510(k) clearance on 2023-05-12. It is manufactured by Teknimed. The 510(k) number is K230394.

When was EUROSCREW NG; EUROSCREW TCP NG approved by the FDA?

EUROSCREW NG; EUROSCREW TCP NG received FDA 510(k) clearance on 2023-05-12, under approval number K230394.

What company makes EUROSCREW NG; EUROSCREW TCP NG?

EUROSCREW NG; EUROSCREW TCP NG is manufactured by Teknimed.

What is the FDA product code for EUROSCREW NG; EUROSCREW TCP NG?

The FDA product code for EUROSCREW NG; EUROSCREW TCP NG is MAI.

Related Devices (Code: MAI)

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.