|
Trade Name | REFLECT™ Scoliosis Correction System |
Classification Name | vertebral body tethering system |
Generic Name | vertebral body tethering system |
Applicant |
Globus Medical, Inc. |
valley forge business center |
2560 general armistead avenue |
audubon, PA 19403 |
|
HDE Number | H210002 |
Supplement Number | S001 |
Date Received | 06/13/2023 |
Decision Date | 07/13/2023 |
Product Code | |
Advisory Committee |
Orthopedic |
Clinical Trials |
NCT03194568
|
Supplement Type | normal 75 day track |
Supplement Reason | postapproval study protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the protocol for the post-approval study (pas). |