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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 the device name listed in this FDA 510(k) record. The listed applicant is Smith and Nephew, Inc.. It received FDA 510(k) clearance on 2019-03-12 under 510(k) 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. The listed applicant is Smith and Nephew, Inc.. The 510(k) number is K183232.

When did Double ENDOBUTTON Fixation Device receive FDA 510(k) clearance?

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

Who is the listed applicant for Double ENDOBUTTON Fixation Device?

The FDA 510(k) record lists Smith and Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Smith and Nephew, Inc. as applicant

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Related Devices (Code: HTN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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