K153211

Substantially Equivalent

M-Fix Acromioclavicular Device

Applicant: Coracoid Solutions, Inc.
Product code: HTN
Advisory panel: Orthopedic
Date received: 2015-11-05
Decision date: 2016-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Park City, UT, US

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.