PMA P200022S008

Device
Simplify® Cervical Artificial Disc
Applicant
Nuvasive, Inc.
PMA number
P200022
Supplement
S008
Product code
MJO
Decision date
2022-02-09
Generic name
Prosthesis, intervertebral disc
Approval order statement
Changes to the location of a mid-process inspection of device components due to acquisition and transfer of ownership.

Current openFDA PMA Record#

Device
Simplify® Cervical Artificial Disc
Applicant
Nuvasive, Inc.
PMA number
P200022
Supplement
S008
Product code
MJO
Generic name
Prosthesis, intervertebral disc
Decision date
2022-02-09
Decision code
OK30
Date received
2022-01-14
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Changes to the location of a mid-process inspection of device components due to acquisition and transfer of ownership.