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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device.
 
Trade NameREFLECT™ Scoliosis Correction System
Classification Namevertebral body tethering system
Generic Namevertebral body tethering system
Applicant
Globus Medical, Inc.
valley forge business center
2560 general armistead ave.
audubon, PA 19403
HDE NumberH210002
Supplement NumberS001
Date Received06/13/2023
Decision Date07/13/2023
Product Code
QHP[ Registered Establishments with QHP ]
Advisory Committee Orthopedic
Clinical Trials NCT03194568
Supplement Typenormal 75 day track
Supplement Reason postapproval study protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval of the protocol for the post-approval study (pas).
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