This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the mobi-c® cervical disc prosthesis. This device is indicated in skeletally mature patients for reconstruction of the disc at one level from c3-c7 following single-level discectomy for intractableradiculopathy (arm pain and/or a neurological deficit) with or without neck pain or myelopathy due to a single-level abnormality localized to the level of the disc space and at least one of the following conditions confirmed by radiographic imaging (ct, mri, x-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height compared to adjacent levels. The mobi-c® cervical disc prosthesis is implanted using an anterior approach. Patients should have failed at least 6 weeks of conservative treatment ordemonstrated progressive signs or symptoms despite nonoperative treatment prior to implantation of the mobi-c® cervical disc prosthesis.
| Device | MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION) |
| Classification Name | Prosthesis, Intervertebral Disc |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | LDR Spine USA |
| Date Received | 2011-01-14 |
| Decision Date | 2013-08-07 |
| Notice Date | 2013-08-22 |
| PMA | P110002 |
| Supplement | S |
| Product Code | MJO |
| Docket Number | 13M-0987 |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | LDR Spine USA 13785 Research Boulevard suite 200 austin, TX 78750 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |