DeviceClearance

K002152

Substantially Equivalent

TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION

Applicant
KLS-Martin L.P.
Product code
MQN
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
New Port Riche, 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.