HDE supplement
H190005 S007: The Tether - Vertebral Body Tethering System
FDA HDE supplement · 30-day notice · Zimmer Biomet Spine, Inc.
Key facts
| Original HDE | H190005 |
|---|---|
| Supplement number | S007 |
| Supplement type | 30-day notice |
| Reason for the supplement | process change - manufacturer/sterilizer/packager/supplier |
| Trade name | The Tether - Vertebral Body Tethering System |
| Generic name | Vertebral body tethering system |
| Applicant | Zimmer Biomet Spine, Inc. |
| Product code | QHP |
| Received date | May 18, 2021 |
| Decision date | Jun 17, 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: