DeviceClearance

K050519

Substantially Equivalent

ADVANCED TURBO DRIVE SYSTEM

Applicant
Linvatec Corp.
Product code
GEY
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Largo, FL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code GEY

product code GEY
Malfunction
7,488
Total
7,488

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.