PMA P170036S006
- Device
- M6-C Artificial Cervical Disc
- Applicant
- Spinal Kinetics, LLC
- PMA number
- P170036
- Supplement
- S006
- Product code
- MJO
- Decision date
- 2020-10-08
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- M6-C Artificial Cervical Disc
- Applicant
- Spinal Kinetics, LLC
- PMA number
- P170036
- Supplement
- S006
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2020-10-08
- Decision code
- APPR
- Date received
- 2020-09-11
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.