DeviceClearance

K191393

Substantially Equivalent

INFINITY Total Ankle System, INBONE Total Ankle System

Applicant
Wrightmedicaltechnologyinc
Product code
HSN
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 HSN

product code HSN
Death
3
Injury
4,711
Total
4,714

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.