DeviceClearance

K101168

Substantially Equivalent

LEGEND POWER ADAPTER MODEL: 6475000

Applicant
Medtronic Sofamor Danek
Product code
HBB
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Memphis, TN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code HBB

product code HBB
Malfunction
2,656
Total
2,656

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.