PMA P110009S024
- Device
- Mobi-C Cervical Disc Prosthesis (Two-Level Indication)
- Applicant
- Highridge Medical, LLC
- PMA number
- P110009
- Supplement
- S024
- Product code
- MJO
- Decision date
- 2020-04-16
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- Modification of manufacturing process of the Mobi-C trials.
Current openFDA PMA Record#
- Device
- Mobi-C Cervical Disc Prosthesis (Two-Level Indication)
- Applicant
- Highridge Medical, LLC
- PMA number
- P110009
- Supplement
- S024
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2020-04-16
- Decision code
- OK30
- Date received
- 2020-03-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification of manufacturing process of the Mobi-C trials.