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.
To qualify an existing manufacturing site as an alternate supplier to perform the titanium (ti) and hydroxyapatite (ha) coating operations for the mobi-c® implant endplates
| Device | Mobi-C Cervical Disc Prosthesis One-level |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | Zimmer Biomet Spine, Inc. |
| Date Received | 2021-01-19 |
| Decision Date | 2021-02-17 |
| PMA | P110002 |
| Supplement | S029 |
| 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 |
|---|---|---|
| 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 |