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 to the control box for the ol1000, ol1000 single coil (size 2/3/4), and spinalogic devices including enlarged lcd icon graphics and prompts, 9 volt alkaline battery power source, and updated device software. The device, as modified, will be marketed under the trade name spinalogic, ol1000, and ol1000 single coil bone growth stimulators. The ol1000 and ol1000 sc devices are intended for the non-invasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. The spinalogic device is indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels.
| Device | SPINALOGIC, OL1000, AND OL1000 SINGLE COIL BONE GROWTH STIMULATORS |
| Classification Name | Stimulator, Bone Growth, Non-invasive |
| Generic Name | Stimulator, Bone Growth, Non-invasive |
| Applicant | DJO, LLC |
| Date Received | 2007-02-05 |
| Decision Date | 2007-06-28 |
| PMA | P910066 |
| Supplement | S023 |
| Product Code | LOF |
| Advisory Committee | Orthopedic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |