|
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 | S003 |
Date Received | 06/09/2020 |
Decision Date | 06/23/2020 |
Product Code | |
Advisory Committee |
Orthopedic |
Supplement Type | normal 75 day track |
Supplement Reason | postapproval study protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the revised protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for h190005. |