HDE
H200001: Patient Specific Talus Spacer
FDA Humanitarian Device Exemption · Paragon 28, Inc.
Key facts
| HDE number | H200001 |
|---|---|
| Trade name | Patient Specific Talus Spacer |
| Generic name | Talus spacer |
| Applicant | Paragon 28, Inc. |
| Owner/operator | Paragon 28 |
| Product code | QNN |
| Approval date | Feb 17, 2021 |
| Docket number | 21M-0203 |
| Notice date | Feb 18, 2021 |
| Establishment registration | 3008650117 |
| FEI number | 3008650117 |
At a glance
- 1–9 Supplements
- Feb 24, 2026 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 1–9 UDI device identifiers (GUDID)
- 1–9 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: