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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 | S007 |
Date Received | 05/18/2021 |
Decision Date | 06/17/2021 |
Product Code | |
Advisory Committee |
Orthopedic |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for addition of new set screw packaging to the existing implant kit. |