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 to *remove the following precaution from the summary of safety and effectiveness and professional labeling; "the safety and effectiveness of the spinalogic(r) has only been studied in patients having spinal fusion treatment. The safety and effectiveness of this device in patients receiving instrumentation, which may distort the magnetic field generated by the device and thus produce a less effective treatment, has not been established"; and *modify the following statement i nthe risks and benefits section of the patient labeling from: "the safety and benefit of the spinalogic(r) was not studied for patients who also have metal implants at the spot of their back surgery," to "the spinalogic(r) was not studied for patients who also have metal implants at the spot of their back surgery. "
| Device | SPINALOGIC BONE GROWTH STIMULATOR |
| Classification Name | Stimulator, Bone Growth, Non-invasive |
| Generic Name | Stimulator, Bone Growth, Non-invasive |
| Applicant | DJO, LLC |
| Date Received | 2000-03-31 |
| Decision Date | 2000-08-23 |
| PMA | P910066 |
| Supplement | S015 |
| Product Code | LOF |
| Advisory Committee | Orthopedic |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DJO, LLC 1430 Decision Street vista, CA 92081-8553 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P910066 | Original Filing | |
| S031 | 2019-10-23 | Real-time Process |
| S030 | 2019-07-03 | 30-day Notice |
| S029 | 2018-05-23 | 30-day Notice |
| S028 | 2016-01-19 | Special (immediate Track) |
| S027 | 2015-06-24 | Special (immediate Track) |
| S026 | 2012-05-09 | Normal 180 Day Track No User Fee |
| S025 | 2008-06-12 | Normal 180 Day Track |
| S024 | 2007-10-12 | Real-time Process |
| S023 | 2007-02-05 | Real-time Process |
| S022 | 2006-08-31 | Normal 180 Day Track No User Fee |
| S021 | 2005-06-01 | Real-time Process |
| S020 | 2004-09-03 | Normal 180 Day Track No User Fee |
| S019 | 2004-01-20 | Normal 180 Day Track |
| S018 | ||
| S017 | 2002-12-20 | Normal 180 Day Track |
| S016 | 2001-04-11 | Real-time Process |
| S015 | 2000-03-31 | Real-time Process |
| S014 | 2000-02-15 | Real-time Process |
| S013 | 1999-02-22 | Real-time Process |
| S012 | 1998-09-22 | Real-time Process |
| S011 | 1998-08-20 | Panel Track |
| S010 | ||
| S009 | 1998-07-06 | Real-time Process |
| S008 | 1997-12-30 | Normal 180 Day Track |
| S007 | 1997-11-17 | Normal 180 Day Track |
| S006 | ||
| S005 | 1997-02-26 | Real-time Process |
| S004 | 1996-04-05 | Normal 180 Day Track |
| S003 | ||
| S002 | 1996-02-20 | Normal 180 Day Track |
| S001 |