DeviceClearance

K212512

Substantially Equivalent

G7® Vivacit-E® Freedom® Constrained Liner

Applicant
Zimmer, Inc.
Product code
PBI
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 PBI

product code PBI
Injury
499
Malfunction
729
Total
1,228

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.