|
Device | MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION) |
Generic Name | Prosthesis, intervertebral disc |
Applicant | Zimmer Biomet Spine, Inc. 10225 Westmoor Drive Westminster, CO 80021 |
PMA Number | P110002 |
Supplement Number | S018 |
Date Received | 04/26/2017 |
Decision Date | 05/23/2017 |
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 that include the addition of a Jex abrasive wheel to the cleaning (deburring) process. |