PMA P110009S018
- Device
- Mobi-C Cervical Disc Prosthesis for use at One or Two Levels
- Applicant
- Highridge Medical, LLC
- PMA number
- P110009
- Supplement
- S018
- Product code
- MJO
- Decision date
- 2017-05-23
- Classification
- Prosthesis, Intervertebral Disc
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- Manufacturing changes that include the addition of a Jex abrasive wheel to the cleaning (deburring) process.
Current openFDA PMA Record#
- Device
- Mobi-C Cervical Disc Prosthesis for use at One or Two Levels
- Applicant
- Highridge Medical, LLC
- PMA number
- P110009
- Supplement
- S018
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2017-05-23
- Decision code
- OK30
- Date received
- 2017-04-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing changes that include the addition of a Jex abrasive wheel to the cleaning (deburring) process.