- Device
- MOBI-C CERVICAL DISC PROSTHESIS
- Applicant
- Highridge Medical, LLC
- PMA number
- P110009
- Supplement
- S016
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2017-03-03
- Decision code
- APPR
- Date received
- 2016-11-01
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Millstone Medical Outsourcing, 8836 Polk Lane, Suite 100, Olive Branch Mississippi for kitting and shipping of new components as well as reconditioning and servicing of used instruments from the field for reuse.