DeviceClearance

K253727

Substantially Equivalent

Syndesmosis TightRope PRO

Applicant
Arthrex, Inc.
Product code
HTN
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Naples, FL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code HTN

product code HTN
Injury
310
Malfunction
639
Total
949

Source: openFDA MAUDE database, through . 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.