|
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 | S012 |
Date Received | 06/05/2015 |
Decision Date | 06/30/2015 |
Product Code |
MJO |
Advisory Committee |
Orthopedic |
Supplement Type | special (immediate track) |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CLARIFICATIONS IN THE SURGICAL TECHNIQUE MANUAL. |