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.
Change to the indications for use and will be marked under the tradename spinalogic.
| Device | ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR |
| Classification Name | Stimulator, Bone Growth, Non-invasive |
| Generic Name | Stimulator, Bone Growth, Non-invasive |
| Applicant | DJO, LLC |
| Date Received | 1998-08-20 |
| Decision Date | 1999-12-17 |
| PMA | P910066 |
| Supplement | S011 |
| Product Code | LOF |
| Docket Number | 00M-1073 |
| Advisory Committee | Orthopedic |
| Supplement Type | Panel Track |
| 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 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| 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 |