This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval of the revised protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p170036.
| Device | M6-C Artificial Cervical Disc |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | Spinal Kinetics LLC |
| Date Received | 2020-09-11 |
| Decision Date | 2020-10-08 |
| PMA | P170036 |
| Supplement | S006 |
| Product Code | MJO |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Spinal Kinetics LLC 501 Mercury Drive sunnyvale, CA 94085 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P170036 | Original Filing | |
| S012 | 2022-10-17 | 30-day Notice |
| S011 | 2022-06-09 | 30-day Notice |
| S010 | 2022-03-08 | 30-day Notice |
| S009 | 2021-09-29 | 30-day Notice |
| S008 | 2020-12-22 | Normal 180 Day Track No User Fee |
| S007 | 2020-09-17 | 30-day Notice |
| S006 | 2020-09-11 | Normal 180 Day Track No User Fee |
| S005 | 2020-02-05 | 30-day Notice |
| S004 | 2020-01-09 | 30-day Notice |
| S003 | 2019-08-15 | 30-day Notice |
| S002 | 2019-04-17 | 30-day Notice |
| S001 |