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.
To modify the inspection process for the m6-c™ artificial cervical disc
Device | M6-C Artificial Cervical Disc |
Classification Name | Prosthesis, Intervertebral Disc |
Generic Name | Prosthesis, Intervertebral Disc |
Applicant | Spinal Kinetics LLC |
Date Received | 2019-08-15 |
Decision Date | 2019-09-05 |
PMA | P170036 |
Supplement | S003 |
Product Code | MJO |
Advisory Committee | Orthopedic |
Supplement Type | 30-day Notice |
Supplement Reason | Process 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 |