PMA P050010S001
- Device
- PRODISC-L TOTAL DISC REPLACEMENT
- Applicant
- Centinel Spine, LLC
- PMA number
- P050010
- Supplement
- S001
- Product code
- MJO
- Decision date
- 2008-01-25
- Classification
- Prosthesis, Intervertebral Disc
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- APPROVAL FOR NEW POLYETHYLENE INLAYS WITH A TANTALUM RADIOGRAPHIC MARKER EMBEDDED IN THE ANTERIOR LIP OF THE INLAY.
Current openFDA PMA Record#
- Device
- PRODISC-L TOTAL DISC REPLACEMENT
- Applicant
- Centinel Spine, LLC
- PMA number
- P050010
- Supplement
- S001
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2008-01-25
- Decision code
- APPR
- Date received
- 2007-12-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR NEW POLYETHYLENE INLAYS WITH A TANTALUM RADIOGRAPHIC MARKER EMBEDDED IN THE ANTERIOR LIP OF THE INLAY.