PMA P050010S023
- Device
- prodisc L
- Applicant
- Centinel Spine, LLC
- PMA number
- P050010
- Supplement
- S023
- Product code
- MJO
- Decision date
- 2021-03-15
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- Change to eliminate redundant quality control method regarding endplate coating thickness.
Current openFDA PMA Record#
- Device
- prodisc L
- Applicant
- Centinel Spine, LLC
- PMA number
- P050010
- Supplement
- S023
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2021-03-15
- Decision code
- OK30
- Date received
- 2021-03-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to eliminate redundant quality control method regarding endplate coating thickness.