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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 NumberS004
Date Received11/02/2020
Decision Date12/02/2020
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 zimmer biomet spine end of line operations facility (zbsel), located at 5400 meltech blvd. , memphis, tennessee for reprocessing activities.
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