HDE
H080004: OPRA
FDA Humanitarian Device Exemption · INTEGRUM AB
Key facts
| HDE number | H080004 |
|---|---|
| Trade name | OPRA |
| Generic name | Osseoanchored prostheses for the rehabilitation of transfemoral amputees |
| Applicant | INTEGRUM AB |
| Owner/operator | Integrum AB |
| Product code | PJY |
| Approval date | Jul 16, 2015 |
| Docket number | 15M-2584 |
| Notice date | Jul 17, 2015 |
| Establishment registration | 3011386779 |
| FEI number | 3011386779 |
At a glance
- 1–9 Supplements
- Mar 13, 2020 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 100–999 UDI device identifiers (GUDID)
- 10–99 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: