PMA P050010S026
- Device
- prodisc® L
- Applicant
- Centinel Spine, LLC
- PMA number
- P050010
- Supplement
- S026
- Product code
- MJO
- Decision date
- 2025-01-17
- Classification
- Orthopedic
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- Change the prodisc L inlays identification process from CO2 laser marking to CNC engraving.
Current openFDA PMA Record#
- Device
- prodisc® L
- Applicant
- Centinel Spine, LLC
- PMA number
- P050010
- Supplement
- S026
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2025-01-17
- Decision code
- OK30
- Date received
- 2024-12-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change the prodisc L inlays identification process from CO2 laser marking to CNC engraving.