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.
For a new manufacturing site to be used for kitting and shipping of mobi-c as well as reconditioning and servicing of instruments from the field for reuse
| Device | Mobi-C Cervical Disc Prosthesis (for Two-Level) |
| Classification Name | Prosthesis, Intervertebral Disc |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | LDR SPINE USA INC. |
| Date Received | 2019-09-04 |
| Decision Date | 2019-11-13 |
| PMA | P110009 |
| Supplement | S022 |
| 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 | LDR SPINE USA INC. 13785 Research Boulevard suite 200 austin, TX 78750 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110009 | Original Filing | |
| S034 | 2022-11-08 | 30-day Notice |
| S033 | ||
| S032 | 2022-01-21 | 135 Review Track For 30-day Notice |
| 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 | Special (immediate Track) |
| S001 | 2013-09-12 | Normal 180 Day Track No User Fee |