HDE supplement
H190005 S012: The Tether™ - Vertebral Body Tethering System
FDA HDE supplement · normal 75 day track · Zimmer Biomet Spine, Inc.
Key facts
| Original HDE | H190005 |
|---|---|
| Supplement number | S012 |
| Supplement type | normal 75 day track |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | The Tether™ - Vertebral Body Tethering System |
| Generic name | Vertebral body tethering system |
| Applicant | Zimmer Biomet Spine, Inc. |
| Product code | QHP |
| Received date | Sep 30, 2024 |
| Decision date | Dec 6, 2024 |
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: