MicroLink All-Suture Button Fixation System (Radiopaque)— 510(k) K190582

Name: FDA 510(k) clearance K190582
Creator: U.S. Food and Drug Administration
Published: 2019-06-28

Substantially Equivalent

Conmed Corporation

FDA 510(k) clearance K190582 for MicroLink All-Suture Button Fixation System (Radiopaque), Substantially Equivalent on 2019-06-28. Applicant: Conmed Corporation. Device class: 2.

Clearance details

Applicant: Conmed Corporation
Product code: Code HTN
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2019-03-06
Decision date: 2019-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Utica, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HTN

product code HTN

Injury: 310
Malfunction: 639
Total: 949

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.