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.
Company provided final draft labeling modified to reflect to the long-term success rates for the device
| Device | SPINAL-STIM(R) |
| Classification Name | Stimulator, Bone Growth, Non-invasive |
| Generic Name | Stimulator, Bone Growth, Non-invasive |
| Applicant | Orthofix, Inc. |
| Date Received | 1995-04-05 |
| Decision Date | 1996-09-19 |
| PMA | P850007 |
| Supplement | S016 |
| Product Code | LOF |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Orthofix, Inc. 3451 Plano Parkway lewisville, TX 75056 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850007 | Original Filing | |
| S046 | 2022-03-16 | Real-time Process |
| S045 | ||
| S044 | 2020-02-26 | 30-day Notice |
| S043 | 2019-09-16 | 30-day Notice |
| S042 | 2019-06-07 | 30-day Notice |
| S041 | 2019-04-15 | Real-time Process |
| S040 | 2018-09-27 | Real-time Process |
| S039 | 2018-05-24 | Real-time Process |
| S038 | 2017-12-07 | Real-time Process |
| S037 | 2017-08-15 | Normal 180 Day Track |
| S036 | 2017-03-24 | Real-time Process |
| S035 | 2016-07-05 | Normal 180 Day Track |
| S034 | 2015-07-28 | 30-day Notice |
| S033 | 2014-08-01 | 30-day Notice |
| S032 | 2011-10-03 | 30-day Notice |
| S031 | 2011-01-19 | Real-time Process |
| S030 | 2010-01-21 | Normal 180 Day Track No User Fee |
| S029 | 2009-08-04 | 30-day Notice |
| S028 | 2009-05-07 | Real-time Process |
| S027 | 2003-06-04 | Normal 180 Day Track |
| S026 | 2001-02-01 | Normal 180 Day Track |
| S025 | 2000-03-13 | Normal 180 Day Track |
| S024 | 1998-09-22 | Real-time Process |
| S023 | 1998-07-21 | Real-time Process |
| S022 | 1998-06-24 | Real-time Process |
| S021 | 1998-03-03 | Normal 180 Day Track |
| S020 | 1997-08-25 | Normal 180 Day Track |
| S019 | 1996-06-12 | Normal 180 Day Track |
| S018 | 1996-05-07 | Normal 180 Day Track |
| S017 | 1995-06-16 | Normal 180 Day Track |
| S016 | 1995-04-05 | Normal 180 Day Track |
| S015 | ||
| S014 | 1994-03-03 | Normal 180 Day Track |
| S013 | 1992-06-23 | Normal 180 Day Track |
| S012 | 1991-02-21 | Normal 180 Day Track |
| S011 | 1990-11-26 | Normal 180 Day Track |
| S010 | 1990-11-13 | Normal 180 Day Track |
| S009 | ||
| S008 | 1989-11-22 | Normal 180 Day Track |
| S007 | 1989-01-24 | Normal 180 Day Track |
| S006 | 1988-06-06 | Panel Track |
| S005 | 1988-01-28 | Normal 180 Day Track |
| S004 | 1987-08-05 | Normal 180 Day Track |
| S003 | 1987-06-17 | Normal 180 Day Track |
| S002 | 1986-12-10 | Normal 180 Day Track |
| S001 | 1986-06-30 | Normal 180 Day Track |