PMA P110009S026
- Device
- Mobi-C Cervical Disc Prosthesis Two Level
- Applicant
- Highridge Medical, LLC
- PMA number
- P110009
- Supplement
- S026
- Product code
- MJO
- Decision date
- 2020-12-15
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- an additional sealing machine for the secondary packaging/outer pouch for the Mobi-C implant
Current openFDA PMA Record#
- Device
- Mobi-C Cervical Disc Prosthesis Two Level
- Applicant
- Highridge Medical, LLC
- PMA number
- P110009
- Supplement
- S026
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2020-12-15
- Decision code
- OK30
- Date received
- 2020-11-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an additional sealing machine for the secondary packaging/outer pouch for the Mobi-C implant