DeviceClearance

K254165

Substantially Equivalent

Infinity™ OCT System

Applicant
Medtronic Sofamor Danek USA, Inc.
Product code
NKG
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Memphis, TN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code NKG

product code NKG
Death
15
Injury
1,090
Malfunction
529
Total
1,634

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.