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.
Update the cutting fluid and bactericidal agent for the machines used to manufacture mobi-c components.
| Device | LDR Spine Mobi-C Cervical Disc Prosthesis (One Level) |
| Classification Name | Prosthesis, Intervertebral Disc |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | LDR Spine USA |
| Date Received | 2018-04-17 |
| Decision Date | 2018-05-15 |
| PMA | P110002 |
| Supplement | S021 |
| 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 | LDR Spine USA 13785 Research Boulevard suite 200 austin, TX 78750 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110002 | Original Filing | |
| S034 | 2022-11-08 | 30-day Notice |
| S033 | ||
| S032 | ||
| S031 | 2021-10-05 | 30-day Notice |
| S030 | 2021-04-08 | 30-day Notice |
| S029 | 2021-01-19 | 30-day Notice |
| S028 | ||
| S027 | ||
| S026 | 2020-11-23 | 30-day Notice |
| S025 | ||
| S024 | 2020-03-17 | 30-day Notice |
| S023 | 2020-01-21 | 30-day Notice |
| S022 | 2019-09-04 | Normal 180 Day Track No User Fee |
| S021 | 2018-04-17 | 30-day Notice |
| S020 | 2018-01-05 | Normal 180 Day Track No User Fee |
| S019 | 2017-05-05 | 30-day Notice |
| S018 | 2017-04-26 | 30-day Notice |
| S017 | ||
| S016 | 2016-11-01 | Normal 180 Day Track No User Fee |
| S015 | 2016-09-30 | Normal 180 Day Track No User Fee |
| S014 | ||
| S013 | 2015-12-31 | 30-day Notice |
| S012 | 2015-06-05 | Special (immediate Track) |
| S011 | 2015-04-20 | Normal 180 Day Track |
| S010 | 2015-04-06 | Normal 180 Day Track No User Fee |
| S009 | 2014-12-08 | Real-time Process |
| S008 | 2014-12-08 | 30-day Notice |
| S007 | 2014-06-27 | 30-day Notice |
| S006 | 2014-04-04 | 30-day Notice |
| S005 | 2014-03-28 | Normal 180 Day Track No User Fee |
| S004 | 2014-01-24 | 30-day Notice |
| S003 | 2013-11-18 | 30-day Notice |
| S002 | 2013-09-12 | Normal 180 Day Track No User Fee |
| S001 | 2013-09-12 | Normal 180 Day Track No User Fee |