M-Fix Acromioclavicular Device— 510(k) K153211

Name: FDA 510(k) clearance K153211
Creator: U.S. Food and Drug Administration
Published: 2016-02-02

Substantially Equivalent

Coracoid Solutions, Inc.

FDA 510(k) clearance K153211 for M-Fix Acromioclavicular Device, Substantially Equivalent on 2016-02-02. Applicant: Coracoid Solutions, Inc.. Device class: 2.

Clearance details

Applicant: Coracoid Solutions, Inc.
Product code: Code HTN
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2015-11-05
Decision date: 2016-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Park City, UT, 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.