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.
Change in process flow order and addition of temporary storage location
| Device | Mobi-C Cervical Disc Prosthesis |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | Zimmer Biomet Spine, Inc. |
| Date Received | 2020-01-21 |
| Decision Date | 2020-02-18 |
| PMA | P110009 |
| Supplement | S023 |
| 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 | Zimmer Biomet Spine, Inc. 10225 Westmoor Drive westminster, CO 80021 |
| 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 |