DeviceClearance

K172502

Substantially Equivalent

Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate

Applicant
Biomet Manufacturing Corp
Product code
PHX
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Warsaw, IN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code PHX

product code PHX
Death
10
Injury
9,705
Malfunction
1,252
Total
10,967

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.