|
Device | LDR Spine Mobi-C Cervical Disc Prosthesis (One Level) |
Generic Name | Prosthesis, intervertebral disc |
Applicant | Zimmer Biomet Spine, Inc. 10225 Westmoor Drive Westminster, CO 80021 |
PMA Number | P110002 |
Supplement Number | S021 |
Date Received | 04/17/2018 |
Decision Date | 05/15/2018 |
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 Update the cutting fluid and bactericidal agent for the machines used to manufacture Mobi-C components. |