PMA P120024S007
- Device
- activL Artificial Disc
- Applicant
- Highridge Medical, LLC
- PMA number
- P120024
- Supplement
- S007
- Product code
- MJO
- Decision date
- 2018-08-10
- Classification
- Prosthesis, Intervertebral Disc
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- Approval for a manufacturing process flow change to the milling process for the PE inlay of the device.
Current openFDA PMA Record#
- Device
- activL Artificial Disc
- Applicant
- Highridge Medical, LLC
- PMA number
- P120024
- Supplement
- S007
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2018-08-10
- Decision code
- APPR
- Date received
- 2017-11-06
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing process flow change to the milling process for the PE inlay of the device.