PMA P110002S021
- Device
- LDR Spine Mobi-C Cervical Disc Prosthesis (One Level)
- Applicant
- Highridge Medical, LLC
- PMA number
- P110002
- Supplement
- S021
- Product code
- MJO
- Decision date
- 2018-05-15
- Classification
- Prosthesis, Intervertebral Disc
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- Update the cutting fluid and bactericidal agent for the machines used to manufacture Mobi-C components.
Current openFDA PMA Record#
- Device
- LDR Spine Mobi-C Cervical Disc Prosthesis (One Level)
- Applicant
- Highridge Medical, LLC
- PMA number
- P110002
- Supplement
- S021
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2018-05-15
- Decision code
- OK30
- Date received
- 2018-04-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the cutting fluid and bactericidal agent for the machines used to manufacture Mobi-C components.