PMA P170036S007
- Device
- M6-C Artificial Cervical Disc
- Applicant
- Spinal Kinetics, LLC
- PMA number
- P170036
- Supplement
- S007
- Product code
- MJO
- Decision date
- 2020-10-14
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- Add a new Cervical Flexural Resistance (CER-FR) tester.
Current openFDA PMA Record#
- Device
- M6-C Artificial Cervical Disc
- Applicant
- Spinal Kinetics, LLC
- PMA number
- P170036
- Supplement
- S007
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2020-10-14
- Decision code
- OK30
- Date received
- 2020-09-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a new Cervical Flexural Resistance (CER-FR) tester.