HDE
H170001: Minimally Invasive Deformity Correction (MID-C) System
FDA Humanitarian Device Exemption · ApiFix, Ltd.
Key facts
| HDE number | H170001 |
|---|---|
| Trade name | Minimally Invasive Deformity Correction (MID-C) System |
| Generic name | Posterior ratcheting rod system |
| Applicant | ApiFix, Ltd. |
| Owner/operator | ApiFix LTD |
| Product code | QGP |
| Approval date | Aug 23, 2019 |
| Docket number | 19M-4007 |
| Notice date | Aug 19, 2019 |
| Establishment registration | 3013461531 |
| FEI number | 3013461531 |
At a glance
- 10–99 Supplements
- Dec 12, 2024 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 10–99 UDI device identifiers (GUDID)
- 100–999 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: