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FDA 510(k)

Double ENDOBUTTON Fixation Device

K-Number: K183232 · 2019-03-12

ApplicantSmith and Nephew, Inc.
Decision Date2019-03-12
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Double ENDOBUTTON Fixation Device is a medical device manufactured by Smith and Nephew, Inc.. It received FDA 510(k) clearance on 2019-03-12 under approval number K183232. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Double ENDOBUTTON Fixation Device?

Double ENDOBUTTON Fixation Device is a medical device that received FDA 510(k) clearance on 2019-03-12. It is manufactured by Smith and Nephew, Inc.. The 510(k) number is K183232.

When was Double ENDOBUTTON Fixation Device approved by the FDA?

Double ENDOBUTTON Fixation Device received FDA 510(k) clearance on 2019-03-12, under approval number K183232.

What company makes Double ENDOBUTTON Fixation Device?

Double ENDOBUTTON Fixation Device is manufactured by Smith and Nephew, Inc..

What is the FDA product code for Double ENDOBUTTON Fixation Device?

The FDA product code for Double ENDOBUTTON Fixation Device is HTN.

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Other Devices by Smith and Nephew, Inc.

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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.

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