PMA P110009S020
- Device
- Mobi-C Cervical Disc Prosthesis
- Applicant
- Highridge Medical, LLC
- PMA number
- P110009
- Supplement
- S020
- Product code
- MJO
- Decision date
- 2018-05-30
- Classification
- Prosthesis, Intervertebral Disc
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- Approval for an update of labeling with 84 month data.
Current openFDA PMA Record#
- Device
- Mobi-C Cervical Disc Prosthesis
- Applicant
- Highridge Medical, LLC
- PMA number
- P110009
- Supplement
- S020
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2018-05-30
- Decision code
- APPR
- Date received
- 2018-01-05
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for an update of labeling with 84 month data.