|
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 | S033 |
Date Received | 02/15/2022 |
Decision Date | 01/12/2023 |
Product Code |
MJO |
Advisory Committee |
Orthopedic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for qualifying alternative detergents Deconex MT12 & MT13 used for cleaning of the Mobi-C implant and a sub-supplier change to KEYBIO. |