PMA P170036S009
- Device
- M6-C Artificial Cervial Disc
- Applicant
- Spinal Kinetics, LLC
- PMA number
- P170036
- Supplement
- S009
- Product code
- MJO
- Decision date
- 2021-10-12
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- Add a new burst tester.
Current openFDA PMA Record#
- Device
- M6-C Artificial Cervial Disc
- Applicant
- Spinal Kinetics, LLC
- PMA number
- P170036
- Supplement
- S009
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2021-10-12
- Decision code
- OK30
- Date received
- 2021-09-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a new burst tester.