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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 NumberS010
Date Received02/20/2024
Decision Date03/21/2024
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 for a manufacturing site, named rms company, located at 8600 evergreen blvd nw minneapolis mn, for post-manufacture cleaning.
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