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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 drive
westminster, CO 80021
HDE NumberH190005
Supplement NumberS006
Date Received05/10/2021
Decision Date06/04/2021
Product Code
QHP[ Registered Establishments with QHP ]
Advisory Committee Orthopedic
Supplement Typenormal 75 day track
Supplement Reason postapproval study protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval of the revised protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for h190005.
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