DeviceClearance

K251444

Substantially Equivalent

Endoskeleton™ Interbody Systems

Applicant
Medtronic Sofamor Danek USA, Inc.
Product code
MAX
Advisory panel
Orthopedic
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 MAX

product code MAX
Death
13
Injury
1,305
Malfunction
2,885
Total
4,203

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.