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Trade Name | The Tether™ - Vertebral Body Tethering System |
Classification Name | vertebral body tethering system |
Generic Name | vertebral body tethering system |
Applicant |
Zimmer Biomet Spine, Inc. |
10225 westmoor drive |
westminster, CO 80021 |
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HDE Number | H190005 |
Supplement Number | S005 |
Date Received | 03/29/2021 |
Decision Date | 06/10/2021 |
Product Code | |
Advisory Committee |
Orthopedic |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for new instruments being added to the tether instrumentation offering: anchor inserter outer and inner tubes, counter tensioner, and rack tensioner. |