PMA P050010S014
- Device
- SYNTHES PRODISC-L TOTAL DISC REPLACEMENT
- Applicant
- Centinel Spine, LLC
- PMA number
- P050010
- Supplement
- S014
- Product code
- MJO
- Decision date
- 2014-05-28
- Classification
- Prosthesis, Intervertebral Disc
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- APPROVAL TO ADD ADDITIONAL ENDPLATES AS A LINE EXTENSION.
Current openFDA PMA Record#
- Device
- SYNTHES PRODISC-L TOTAL DISC REPLACEMENT
- Applicant
- Centinel Spine, LLC
- PMA number
- P050010
- Supplement
- S014
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2014-05-28
- Decision code
- APPR
- Date received
- 2012-12-07
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO ADD ADDITIONAL ENDPLATES AS A LINE EXTENSION.