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.
Modified fixture used for inspection of the prodisc-c endplates.
| Device | PRODISC-C TOTAL DISC REPLACEMENT |
| Classification Name | Prosthesis, Intervertebral Disc |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | Centinel Spine, LLC |
| Date Received | 2010-06-02 |
| Decision Date | 2010-07-02 |
| PMA | P070001 |
| Supplement | S007 |
| 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 | Centinel Spine, LLC 900 Airport Road, Suite 3b west Chester, PA 19380 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P070001 | Original Filing | |
| S021 | 2021-09-21 | 30-day Notice |
| S020 | 2021-01-28 | 30-day Notice |
| S019 | ||
| S018 | 2019-06-21 | Normal 180 Day Track No User Fee |
| S017 | 2018-12-04 | Normal 180 Day Track No User Fee |
| S016 | 2017-09-20 | 30-day Notice |
| S015 | 2017-06-30 | 30-day Notice |
| S014 | ||
| S013 | 2014-04-03 | 135 Review Track For 30-day Notice |
| S012 | 2012-03-13 | 135 Review Track For 30-day Notice |
| S011 | 2011-07-19 | 30-day Notice |
| S010 | 2011-07-18 | 135 Review Track For 30-day Notice |
| S009 | 2010-08-02 | Real-time Process |
| S008 | 2010-06-07 | 30-day Notice |
| S007 | 2010-06-02 | 30-day Notice |
| S006 | 2010-05-27 | 30-day Notice |
| S005 | 2010-05-27 | 135 Review Track For 30-day Notice |
| S004 | 2010-05-19 | Normal 180 Day Track No User Fee |
| S003 | ||
| S002 | 2008-03-12 | Normal 180 Day Track No User Fee |
| S001 | 2008-01-31 | Real-time Process |