DeviceClearance

K231113

Substantially Equivalent

Arthrex FiberTak Suture Anchor

Applicant
Arthrex, Inc.
Product code
MBI
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 MBI

product code MBI
Injury
3,163
Malfunction
13,006
Other
2
Total
16,171

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.