K103814

Substantially Equivalent

PEZO INTERBODY CAGES SYSTEM

Applicant
Ulrich GmbH & Co. KG
Product code
MAX
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Chesterfield, MO, 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.