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 for infinity labs sd located at 1836 stone avenue, san jose, california, 95125, for ethylene oxide sterilization of the m6-c artificial cervical disc system
| Device | M6-C Artificial Cervical Disc |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | Spinal Kinetics LLC |
| Date Received | 2020-12-22 |
| Decision Date | 2021-08-06 |
| PMA | P170036 |
| Supplement | S008 |
| Product Code | MJO |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| 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 |