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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 | S009 |
Date Received | 06/29/2023 |
Decision Date | 07/28/2023 |
Product Code | |
Advisory Committee |
Orthopedic |
Supplement Type | normal 75 day track |
Supplement Reason | location change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a manufacturing site, named zimmer biomet spine center of excellence (zbsce), located at 7437 polk lane, olive branch, ms, for reclaim operations and end-of-line operations (except for post-manufacturing cleaning). |