HDE
H210002: REFLECT™ Scoliosis Correction System
FDA Humanitarian Device Exemption · Globus Medical, Inc.
Key facts
| HDE number | H210002 |
|---|---|
| Trade name | REFLECT™ Scoliosis Correction System |
| Generic name | Vertebral body tethering system |
| Applicant | Globus Medical, Inc. |
| Owner/operator | GLOBUS MEDICAL, INC. |
| Product code | QHP |
| Approval date | May 15, 2023 |
| Establishment registration | 3004142400 |
| FEI number | 3004142400 |
At a glance
- 1–9 Supplements
- Jul 13, 2023 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 10–99 UDI device identifiers (GUDID)
- 1–9 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: