|
Device | Mobi-C Cervical Disc Prosthesis (one-level indications) |
Generic Name | Prosthesis, intervertebral disc |
Applicant | Zimmer Biomet Spine, Inc. 10225 Westmoor Drive Westminster, CO 80021 |
PMA Number | P110002 |
Supplement Number | S022 |
Date Received | 09/04/2019 |
Decision Date | 11/13/2019 |
Product Code |
MJO |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a new manufacturing site to be used for kitting and shipping of Mobi-C as well as reconditioning and servicing of instruments from the field for reuse. |