|
Device | Mobi-C Cervical Disc Prosthesis Two Level |
Generic Name | Prosthesis, intervertebral disc |
Applicant | Zimmer Biomet Spine, Inc. 10225 Westmoor Drive Westminster, CO 80021 |
PMA Number | P110009 |
Supplement Number | S026 |
Date Received | 11/23/2020 |
Decision Date | 12/15/2020 |
Product Code |
MJO |
Advisory Committee |
Orthopedic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement an additional sealing machine for the secondary packaging/outer pouch for the Mobi-C implant |