HDE
H240001: 4WEB Medical Talar Replacement Device
FDA Humanitarian Device Exemption · 4WEB Medical
Key facts
| HDE number | H240001 |
|---|---|
| Trade name | 4WEB Medical Talar Replacement Device |
| Generic name | Prosthesis, total talus replacement, metal |
| Applicant | 4WEB Medical |
| Owner/operator | 4WEB, INC |
| Product code | QNN |
| Approval date | Dec 27, 2024 |
| Docket number | 25M-0049 |
| Notice date | Jan 10, 2025 |
| Establishment registration | 3009189869 |
| FEI number | 3009189869 |
At a glance
- 1–9 Supplements
- Oct 31, 2025 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE approvals
A Humanitarian Device Exemption (HDE) authorizes devices intended to benefit patients with rare diseases or conditions affecting small populations in the United States.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: