FDA 510(k)

MicroLink All-Suture Button Fixation System (Radiolucent)

K-Number: K190516 · 2019-06-28

Decision Date2019-06-28

Product CodeHTN

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

MicroLink All-Suture Button Fixation System (Radiolucent) is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Corporation. It received FDA 510(k) clearance on 2019-06-28 under 510(k) number K190516. 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 MicroLink All-Suture Button Fixation System (Radiolucent)?

MicroLink All-Suture Button Fixation System (Radiolucent) is a medical device that received FDA 510(k) clearance on 2019-06-28. The listed applicant is Conmed Corporation. The 510(k) number is K190516.

When did MicroLink All-Suture Button Fixation System (Radiolucent) receive FDA 510(k) clearance?

MicroLink All-Suture Button Fixation System (Radiolucent) received FDA 510(k) clearance on 2019-06-28, under 510(k) number K190516.

Who is the listed applicant for MicroLink All-Suture Button Fixation System (Radiolucent)?

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

What is the FDA product code for MicroLink All-Suture Button Fixation System (Radiolucent)?

The FDA product code for MicroLink All-Suture Button Fixation System (Radiolucent) is HTN.

Other records listing Conmed Corporation as applicant

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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.