|
Device | MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION) |
Generic Name | Prosthesis, intervertebral disc |
Applicant | Zimmer Biomet Spine, Inc. 10225 Westmoor Drive Westminster, CO 80021 |
PMA Number | P110009 |
Supplement Number | S008 |
Date Received | 12/08/2014 |
Decision Date | 12/29/2014 |
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 ADDITION OF A MANUFACTURING MACHINE AND A CLEANING PROCESS EQUIPMENT CHANGE. |