DeviceClearance

K210390

Substantially Equivalent

Apex 3D Total Ankle Replacement System

Applicant
Paragon 28, Inc.
Product code
HSN
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Englewood, CO, 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.