HDE supplement
H230003 S001: restor3d Total Talus Replacement
FDA HDE supplement · normal 75 day track · restor3d, Inc.
Key facts
| Original HDE | H230003 |
|---|---|
| Supplement number | S001 |
| Supplement type | normal 75 day track |
| Reason for the supplement | postapproval study protocol |
| Trade name | restor3d Total Talus Replacement |
| Generic name | Prosthesis, total talus replacement, metal |
| Applicant | restor3d, Inc. |
| Product code | QNN |
| Received date | Dec 14, 2023 |
| Decision date | Jan 12, 2024 |
At a glance
- No Approval order on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE supplements
An HDE supplement asks FDA to approve a change to a Humanitarian Use Device that already holds a humanitarian device exemption.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: