|
Device | Mobi-C® Cervical Disc Prosthesis (two-level use) |
Generic Name | Prosthesis, intervertebral disc |
Applicant | Zimmer Biomet Spine, Inc. 10225 Westmoor Drive Westminster, CO 80021 |
PMA Number | P110009 |
Supplement Number | S031 |
Date Received | 10/05/2021 |
Decision Date | 11/01/2021 |
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 Manufacturing changes to the outer layer of the inner pouch of the packaging for the Mobi-C implant. |