DeviceClearance

K102413

Substantially Equivalent

FUZE: INTRAMEDULLARY INTERNAL FIXATION NAIL

Applicant
Vilex, Inc.
Product code
HSB
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mcminnville, TN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code HSB

product code HSB
Death
49
Injury
12,083
Malfunction
6,561
Other
1
Total
18,694

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.