PMA P170036S012
- Device
- M6-C Artificial Cervical Disc
- Applicant
- Spinal Kinetics, LLC
- PMA number
- P170036
- Supplement
- S012
- Product code
- MJO
- Decision date
- 2022-11-01
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- Additional Cervical Instron Tester EQ 0180 and associated Bluehill software to increase manufacturing capacity.
Current openFDA PMA Record#
- Device
- M6-C Artificial Cervical Disc
- Applicant
- Spinal Kinetics, LLC
- PMA number
- P170036
- Supplement
- S012
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2022-11-01
- Decision code
- OK30
- Date received
- 2022-10-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional Cervical Instron Tester EQ 0180 and associated Bluehill software to increase manufacturing capacity.