|
Device | LDR Spine 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 | S032 |
Date Received | 01/21/2022 |
Decision Date | 11/09/2022 |
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 two new cutting oils that are to be used in machining processes at current supplier, In’Tech Medical, sites. |