PMA P200022S013
- Device
- Simplify® Cervical Artificial Disc
- Applicant
- Nuvasive, Inc.
- PMA number
- P200022
- Supplement
- S013
- Product code
- MJO
- Decision date
- 2024-04-17
- Classification
- Orthopedic
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- Approval for updated labeling to reflect the findings of the 1-level extended follow-up of the IDE subjects.
Current openFDA PMA Record#
- Device
- Simplify® Cervical Artificial Disc
- Applicant
- Nuvasive, Inc.
- PMA number
- P200022
- Supplement
- S013
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2024-04-17
- Decision code
- APPR
- Date received
- 2023-10-20
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for updated labeling to reflect the findings of the 1-level extended follow-up of the IDE subjects.