HDE
H190005: The Tether™ - Vertebral Body Tethering System
FDA Humanitarian Device Exemption · Zimmer Biomet Spine, Inc.
Key facts
| HDE number | H190005 |
|---|---|
| Trade name | The Tether™ - Vertebral Body Tethering System |
| Generic name | Vertebral body tethering system |
| Applicant | Zimmer Biomet Spine, Inc. |
| Owner/operator | Highridge Medical, LLC |
| Product code | QHP |
| Approval date | Aug 16, 2019 |
| Docket number | 19M-3863 |
| Notice date | Aug 16, 2019 |
| Establishment registration | 3012447612 |
| FEI number | 3012447612 |
At a glance
- 10–99 Supplements
- Dec 29, 2025 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: