PMA P170036S002

Device
M6-C Artificial Cervical Disc
Applicant
Spinal Kinetics, LLC
PMA number
P170036
Supplement
S002
Product code
MJO
Decision date
2019-05-10
Classification
Prosthesis, Intervertebral Disc
Generic name
Prosthesis, intervertebral disc
Approval order statement
Addition of a new supplier for the instrument trays.

Current openFDA PMA Record#

Device
M6-C Artificial Cervical Disc
Applicant
Spinal Kinetics, LLC
PMA number
P170036
Supplement
S002
Product code
MJO
Generic name
Prosthesis, intervertebral disc
Decision date
2019-05-10
Decision code
OK30
Date received
2019-04-17
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of a new supplier for the instrument trays.