restor3d Kinos Axiom Total Ankle System— 510(k) K240591

Substantially Equivalent

Restor3D, Inc.

FDA 510(k) clearance K240591 for restor3d Kinos Axiom Total Ankle System, Substantially Equivalent on 2024-04-29. Applicant: Restor3D, Inc..

Clearance details

Applicant: Restor3D, Inc.
Product code: Code HSN
Advisory panel: Orthopedic
Date received: 2024-03-01
Decision date: 2024-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, 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, 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.