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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 NumberS014
Date Received05/14/2025
Decision Date06/10/2025
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 for changes to the post-approval study design including an increase to the total enrollment target, a cap on the number of participating clinical sites, allowance for retrospective enrollment from a sponsor-managed registry at select sites, reclassification of fusion reoperations as endpoint failures, and removal of pulmonary function testing and trunk flexibility measurements (for virtual visits only) as data collection requirements.
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