510(k) K192994— Paragon 28 APEX 3D Total Ankle Replacement System

Substantially Equivalent

Paragon 28, Inc.

Clearance details

Applicant: Paragon 28, Inc.
Product code: Code HSN
Advisory panel: Orthopedic
Date received: 2019-10-25
Decision date: 2020-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

Adverse events under product code HSN

product code HSN

Death: 3
Injury: 4,711
Total: 4,714

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.