|
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 | S003 |
Date Received | 08/15/2019 |
Decision Date | 09/05/2019 |
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 Modify the inspection process for the M6-C Artificial Cervical Disc. |