HDE
H230003: restor3d Total Talus Replacement
FDA Humanitarian Device Exemption · restor3d, Inc.
Key facts
| HDE number | H230003 |
|---|---|
| Trade name | restor3d Total Talus Replacement |
| Generic name | Prosthesis, total talus replacement, metal |
| Applicant | restor3d, Inc. |
| Owner/operator | restor3d, inc. |
| Product code | QNN |
| Approval date | Nov 17, 2023 |
| Docket number | 23M-5210 |
| Notice date | Dec 1, 2023 |
| Establishment registration | 3014833750 |
| FEI number | 3014833750 |
At a glance
- 1–9 Supplements
- May 11, 2026 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 100–999 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: