PMA P110002S030
- Device
- Mobi-C® Cervical Disc Prosthesis One-Level
- Applicant
- Highridge Medical, LLC
- PMA number
- P110002
- Supplement
- S030
- Product code
- MJO
- Decision date
- 2021-05-05
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- Increased storage time of the Mobi-C® implant endplates in the existing clean room at Viant from 2 months to 12 months.
Current openFDA PMA Record#
- Device
- Mobi-C® Cervical Disc Prosthesis One-Level
- Applicant
- Highridge Medical, LLC
- PMA number
- P110002
- Supplement
- S030
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2021-05-05
- Decision code
- OK30
- Date received
- 2021-04-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Increased storage time of the Mobi-C® implant endplates in the existing clean room at Viant from 2 months to 12 months.