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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 the device name listed in this FDA 510(k) record. The listed applicant is Teknimed. It received FDA 510(k) clearance on 2023-05-12 under 510(k) 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. The listed applicant is Teknimed. The 510(k) number is K230394.

When did EUROSCREW NG; EUROSCREW TCP NG receive FDA 510(k) clearance?

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

Who is the listed applicant for EUROSCREW NG; EUROSCREW TCP NG?

The FDA 510(k) record lists Teknimed as the applicant. This does not by itself establish the device manufacturer.

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

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

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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.

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