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.
Approval for modifications made to the mobi-c universal inserterinstrument, which included addition of material to increase the inner diameter and a change to the laser marking and passivation process.
Device | MOBI-C CERVICAL DISC PROSTHESIS |
Classification Name | Prosthesis, Intervertebral Disc |
Generic Name | Prosthesis, Intervertebral Disc |
Applicant | LDR SPINE USA INC. |
Date Received | 2014-12-08 |
Decision Date | 2015-02-05 |
PMA | P110009 |
Supplement | S009 |
Product Code | MJO |
Advisory Committee | Orthopedic |
Supplement Type | Real-time Process |
Supplement Reason | Change Design/components/specifications/material |
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 |