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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 NameThe Tether - Vertebral Body Tethering System
Classification Namevertebral body tethering system
Generic Namevertebral body tethering system
Applicant
Zimmer Biomet Spine, Inc.
10225 westmoor dr.
westminister, CO 80021
HDE NumberH190005
Supplement NumberS007
Date Received05/18/2021
Decision Date06/17/2021
Product Code
QHP[ Registered Establishments with QHP ]
Advisory Committee Orthopedic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for addition of new set screw packaging to the existing implant kit.
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