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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Date Received08/12/2021
Decision Date05/15/2023
Product Code
QHP[ Registered Establishments with QHP ]
Docket Number 23M-2054
Notice Date 06/08/2023
Advisory Committee Orthopedic
Clinical Trials NCT03194568
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the reflect™ scoliosis correction system. This device is indicated for skeletally immature patients who require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis, who have a major cobb angle of 30 to 65 degrees and who have failed bracing and/or are intolerant to bracing.
Approval OrderApproval Order
SummarySummary of Safety And Probable Benefit
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 
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