|
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 |
|
HDE Number | H190005 |
Supplement Number | S008 |
Date Received | 08/15/2022 |
Decision Date | 10/14/2022 |
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 updates to the tolerances and inspection criteria of the vertebral body screw. |