|
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 | S009 |
Date Received | 12/08/2014 |
Decision Date | 02/05/2015 |
Product Code |
MJO |
Advisory Committee |
Orthopedic |
Supplement Type | real-time process |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS MADE TO THE MOBI-C UNIVERSAL INSERTERINSTRUMENT, WHICH INCLUDED ADDITION OF MATERIAL TO INCREASE THE INNER DIAMETER AND A CHANGE TO THE LASER MARKING AND PASSIVATION PROCESS. |