Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 NumberS002
Date Received09/14/2026
Decision Date10/08/2026
Product Code
QHP[ Registered Establishments with QHP ]
Advisory Committee Orthopedic
Supplement Typenormal 75 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval to manufacture the single and dual staples at branch medical group, located in limerick, pennsylvania.
-
-