PMA P110009S031
- Device
- Mobi-C® Cervical Disc Prosthesis (two-level use)
- Applicant
- Highridge Medical, LLC
- PMA number
- P110009
- Supplement
- S031
- Product code
- MJO
- Decision date
- 2021-11-01
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- Manufacturing changes to the outer layer of the inner pouch of the packaging for the Mobi-C implant.
Current openFDA PMA Record#
- Device
- Mobi-C® Cervical Disc Prosthesis (two-level use)
- Applicant
- Highridge Medical, LLC
- PMA number
- P110009
- Supplement
- S031
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2021-11-01
- Decision code
- OK30
- Date received
- 2021-10-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing changes to the outer layer of the inner pouch of the packaging for the Mobi-C implant.