HDE supplement
H210002 S001: REFLECT™ Scoliosis Correction System
FDA HDE supplement · normal 75 day track · Globus Medical, Inc.
Key facts
| Original HDE | H210002 |
|---|---|
| Supplement number | S001 |
| Supplement type | normal 75 day track |
| Reason for the supplement | postapproval study protocol |
| Trade name | REFLECT™ Scoliosis Correction System |
| Generic name | Vertebral body tethering system |
| Applicant | Globus Medical, Inc. |
| Product code | QHP |
| Received date | Jun 13, 2023 |
| Decision date | Jul 13, 2023 |
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: