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.
| Device | EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR |
| Classification Name | Stimulator, Invasive Bone Growth |
| Generic Name | Stimulator, Invasive Bone Growth |
| Applicant | EBI, LLC |
| Date Received | 1985-05-31 |
| Decision Date | 1987-04-30 |
| Notice Date | 1987-06-10 |
| PMA | P850035 |
| Supplement | S |
| Product Code | LOE |
| Docket Number | 87M-0174 |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | EBI, LLC 399 Jefferson Road parsippany, NJ 07054 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850035 | Original Filing | |
| S058 | 2022-10-28 | 30-day Notice |
| S057 | 2022-05-27 | Real-time Process |
| S056 | 2021-01-21 | 30-day Notice |
| S055 | 2019-06-21 | 30-day Notice |
| S054 | ||
| S053 | 2018-04-09 | 30-day Notice |
| S052 | 2018-04-04 | 30-day Notice |
| S051 | 2018-04-02 | 135 Review Track For 30-day Notice |
| S050 | 2018-03-29 | 30-day Notice |
| S049 | 2018-03-09 | 30-day Notice |
| S048 | 2018-03-01 | 30-day Notice |
| S047 | 2018-02-21 | 30-day Notice |
| S046 | 2018-02-13 | 30-day Notice |
| S045 | 2017-05-04 | 30-day Notice |
| S044 | 2017-03-14 | 30-day Notice |
| S043 | 2016-10-31 | Special (immediate Track) |
| S042 | 2016-02-19 | Special (immediate Track) |
| S041 | 2015-12-17 | 30-day Notice |
| S040 | 2015-11-19 | 30-day Notice |
| S039 | 2015-10-08 | 30-day Notice |
| S038 | 2014-08-20 | 30-day Notice |
| S037 | ||
| S036 | 2013-09-06 | 30-day Notice |
| S035 | 2013-04-30 | 30-day Notice |
| S034 | 2012-02-01 | 30-day Notice |
| S033 | 2008-07-22 | Normal 180 Day Track No User Fee |
| S032 | 2008-07-17 | 30-day Notice |
| S031 | 2007-02-23 | Real-time Process |
| S030 | 2004-06-09 | Normal 180 Day Track |
| S029 | 2002-06-13 | Normal 180 Day Track |
| S028 | 2000-05-30 | Real-time Process |
| S027 | ||
| S026 | ||
| S025 | 2000-03-31 | Normal 180 Day Track |
| S024 | 1998-07-06 | Normal 180 Day Track |
| S023 | 1998-04-09 | Real-time Process |
| S022 | 1997-04-08 | Real-time Process |
| S021 | 1996-10-17 | Normal 180 Day Track |
| S020 | 1996-07-19 | Normal 180 Day Track |
| S019 | 1996-03-13 | Normal 180 Day Track |
| S018 | 1995-12-08 | Special (immediate Track) |
| S017 | 1994-11-22 | Normal 180 Day Track |
| S016 | 1994-11-15 | Normal 180 Day Track |
| S015 | ||
| S014 | ||
| S013 | 1992-03-27 | Normal 180 Day Track |
| S012 | 1991-05-10 | Normal 180 Day Track |
| S011 | ||
| S010 | 1990-10-25 | Normal 180 Day Track |
| S009 | ||
| S008 | 1990-05-31 | Normal 180 Day Track |
| S007 | 1988-12-16 | Normal 180 Day Track |
| S006 | 1988-10-12 | Normal 180 Day Track |
| S005 | 1988-04-18 | Normal 180 Day Track |
| S004 | 1988-03-16 | Normal 180 Day Track |
| S003 | 1988-02-26 | Normal 180 Day Track |
| S002 | 1988-01-15 | Normal 180 Day Track |
| S001 |
| Device ID | PMA | Supp |
|---|---|---|
| 00812301020096 | P850035 | 032 |
| 00812301020089 | P850035 | 032 |
| 00812301020133 | P850035 | 033 |
| 00812301020126 | P850035 | 033 |