|
Device | Mobi-C Cervical Disc Prosthesis |
Generic Name | Prosthesis, intervertebral disc |
Applicant | Zimmer Biomet Spine, Inc. 10225 Westmoor Drive Westminster, CO 80021 |
PMA Number | P110009 |
Supplement Number | S020 |
Date Received | 01/05/2018 |
Decision Date | 05/30/2018 |
Product Code |
MJO |
Advisory Committee |
Orthopedic |
Clinical Trials | NCT00389597
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an update of labeling with 84 month data. |