HDE supplement
H200001 S007: Patient Specific Talus Spacer
FDA HDE supplement · special (immediate track) · Paragon 28, Inc.
Key facts
| Original HDE | H200001 |
|---|---|
| Supplement number | S007 |
| Supplement type | special (immediate track) |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | Patient Specific Talus Spacer |
| Generic name | Prosthesis, total talus replacement, metal |
| Applicant | Paragon 28, Inc. |
| Product code | QNN |
| Received date | Jun 28, 2024 |
| Decision date | Jul 18, 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: