PMA P110002S008
- Device
- MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION)
- Applicant
- Highridge Medical, LLC
- PMA number
- P110002
- Supplement
- S008
- Product code
- MJO
- Decision date
- 2014-12-29
- Classification
- Prosthesis, Intervertebral Disc
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- ADDITION OF A MANUFACTURING MACHINE AND A CLEANING PROCESS EQUIPMENT CHANGE.
Current openFDA PMA Record#
- Device
- MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION)
- Applicant
- Highridge Medical, LLC
- PMA number
- P110002
- Supplement
- S008
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2014-12-29
- Decision code
- OK30
- Date received
- 2014-12-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A MANUFACTURING MACHINE AND A CLEANING PROCESS EQUIPMENT CHANGE.