PMA P110009S032
- Device
- LDR Spine Mobi-C® Cervical Disc Prosthesis
- Applicant
- Highridge Medical, LLC
- PMA number
- P110009
- Supplement
- S032
- Product code
- MJO
- Decision date
- 2022-11-09
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- Approval for two new cutting oils that are to be used in machining processes at current supplier, In’Tech Medical, sites.
Current openFDA PMA Record#
- Device
- LDR Spine Mobi-C® Cervical Disc Prosthesis
- Applicant
- Highridge Medical, LLC
- PMA number
- P110009
- Supplement
- S032
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2022-11-09
- Decision code
- APPR
- Date received
- 2022-01-21
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for two new cutting oils that are to be used in machining processes at current supplier, In’Tech Medical, sites.