DeviceClearance

K180759

Substantially Equivalent

SECULOK™ Suture Anchor

Applicant
U&I Corporation
Product code
MBI
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Uijeongbu-Si, KR
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.