HDE supplement
H170001 S012: Minimally Invasive Deformity Correction (MID-C) System
FDA HDE supplement · 30-day notice · ApiFix, Ltd.
Key facts
| Original HDE | H170001 |
|---|---|
| Supplement number | S012 |
| Supplement type | 30-day notice |
| Reason for the supplement | process change - manufacturer/sterilizer/packager/supplier |
| Trade name | Minimally Invasive Deformity Correction (MID-C) System |
| Generic name | Posterior ratcheting rod system |
| Applicant | ApiFix, Ltd. |
| Product code | QGP |
| Received date | Apr 12, 2021 |
| Decision date | May 11, 2021 |
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: