PMA P050010S028
- Device
- prodisc L
- Applicant
- Centinel Spine, LLC
- PMA number
- P050010
- Supplement
- S028
- Product code
- MJO
- Decision date
- 2025-07-30
- Classification
- Orthopedic
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- approval for the addition of APS Materials Inc (FEI 1000149660) as an alternate commercially pure titanium raw material supplier
Current openFDA PMA Record#
- Device
- prodisc L
- Applicant
- Centinel Spine, LLC
- PMA number
- P050010
- Supplement
- S028
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2025-07-30
- Decision code
- OK30
- Date received
- 2025-07-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for the addition of APS Materials Inc (FEI 1000149660) as an alternate commercially pure titanium raw material supplier