PMA P200022S007

Device
Simplify Cervical Artificial Disc
Applicant
Nuvasive, Inc.
PMA number
P200022
Supplement
S007
Product code
MJO
Decision date
2021-07-21
Generic name
Prosthesis, intervertebral disc
Approval order statement
Add a second raw material supplier for the raw material used to manufacture the core of the device.

Current openFDA PMA Record#

Device
Simplify Cervical Artificial Disc
Applicant
Nuvasive, Inc.
PMA number
P200022
Supplement
S007
Product code
MJO
Generic name
Prosthesis, intervertebral disc
Decision date
2021-07-21
Decision code
OK30
Date received
2021-06-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Add a second raw material supplier for the raw material used to manufacture the core of the device.