PMA P170036S014

Device
M6-C Artificial Cervical Disc
Applicant
Spinal Kinetics, LLC
PMA number
P170036
Supplement
S014
Product code
MJO
Decision date
2024-06-14
Classification
Orthopedic
Generic name
Prosthesis, intervertebral disc
Approval order statement
approval of use of the Keyence Laser Marking System for marking the device endplate

Current openFDA PMA Record#

Device
M6-C Artificial Cervical Disc
Applicant
Spinal Kinetics, LLC
PMA number
P170036
Supplement
S014
Product code
MJO
Generic name
Prosthesis, intervertebral disc
Decision date
2024-06-14
Decision code
OK30
Date received
2024-05-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
approval of use of the Keyence Laser Marking System for marking the device endplate