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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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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
Date Received06/04/2019
Decision Date08/16/2019
Product Code
QHP[ Registered Establishments with QHP ]
Docket Number 19M-3863
Notice Date 08/16/2019
Advisory Committee Orthopedic
Clinical Trials NCT02897453
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the tether™ - vertebral body tethering system. This device is indicated for skeletally immature patients that require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis, with a major cobb angle of 30 to 65 degrees whose osseous structure is dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging. Patients should have failed bracing and/or be intolerant to brace wear.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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