PMA P070001S019
- Device
- prodisc C: prodisc C SK, prodisc C Nova, prodisc C Vivo
- Applicant
- Centinel Spine, LLC
- Product code
- MJO
- Decision date
- 2022-07-07
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- Approval for a Line Extension to Centinel Spines prodisc® C: the prodisc® C SK, the prodisc® C Nova, and the prodisc® C Vivo.
Current openFDA PMA Record#
- Device
- prodisc C: prodisc C SK, prodisc C Nova, prodisc C Vivo
- Applicant
- Centinel Spine, LLC
- PMA number
- P070001
- Supplement
- S019
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2022-07-07
- Decision code
- APPR
- Date received
- 2020-12-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a Line Extension to Centinel Spines prodisc® C: the prodisc® C SK, the prodisc® C Nova, and the prodisc® C Vivo.