|
Device | M6-C Artificial Cervical Disc |
Generic Name | Prosthesis, intervertebral disc |
Applicant | Spinal Kinetics LLC 501 Mercury Drive Sunnyvale, CA 94085 |
PMA Number | P170036 |
Supplement Number | S002 |
Date Received | 04/17/2019 |
Decision Date | 05/10/2019 |
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 Addition of a new supplier for the instrument trays. |