K042278

Substantially Equivalent

ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5)

Applicant
Oral Osteodistraction, L.P.
Product code
MQN
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Appollo Beach, FL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code MQN

product code MQN
Injury
346
Total
346

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.