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 | BIO OSTEOGEN SYSTEM 204 |
| Classification Name | Stimulator, Bone Growth, Non-invasive |
| Generic Name | Stimulator, Bone Growth, Non-invasive |
| Applicant | EBI, LLC |
| Date Received | 1979-01-15 |
| Decision Date | 1979-11-06 |
| Notice Date | 1980-04-25 |
| PMA | P790002 |
| Supplement | S |
| Product Code | LOF |
| Docket Number | 80M-0057 |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | EBI, LLC 399 Jefferson Road parsippany, NJ 07054 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P790002 | Original Filing | |
| S038 | 2022-10-28 | 30-day Notice |
| S037 | 2018-03-01 | 30-day Notice |
| S036 | 2016-11-08 | 30-day Notice |
| S035 | 2016-02-11 | 30-day Notice |
| S034 | 2015-12-17 | 30-day Notice |
| S033 | 2015-10-08 | 30-day Notice |
| S032 | 2014-04-10 | 30-day Notice |
| S031 | 2014-02-07 | Real-time Process |
| S030 | 2013-08-13 | Special (immediate Track) |
| S029 | 2012-12-04 | 30-day Notice |
| S028 | 2012-05-16 | Normal 180 Day Track |
| S027 | 2011-08-11 | 30-day Notice |
| S026 | 2010-06-29 | Normal 180 Day Track |
| S025 | 2007-04-06 | Real-time Process |
| S024 | ||
| S023 | 2005-06-17 | Real-time Process |
| S022 | 2002-04-08 | Normal 180 Day Track |
| S021 | 1999-11-30 | Real-time Process |
| S020 | 1998-12-22 | Real-time Process |
| S019 | 1998-06-24 | Real-time Process |
| S018 | 1997-02-10 | Normal 180 Day Track |
| S017 | ||
| S016 | 1995-06-02 | Normal 180 Day Track |
| S015 | 1994-07-19 | Normal 180 Day Track |
| S014 | 1992-09-28 | Normal 180 Day Track |
| S013 | 1991-10-28 | Normal 180 Day Track |
| S012 | 1989-08-07 | Normal 180 Day Track |
| S011 | 1989-04-14 | Normal 180 Day Track |
| S010 | 1989-03-02 | Normal 180 Day Track |
| S009 | 1987-06-11 | Normal 180 Day Track |
| S008 | 1986-10-16 | Normal 180 Day Track |
| S007 | ||
| S006 | 1985-04-15 | |
| S005 | ||
| S004 | 1983-03-02 | |
| S003 | 1982-09-15 | |
| S002 | 1982-07-15 | |
| S001 | 1982-04-01 |
| Device ID | PMA | Supp |
|---|---|---|
| 00812301020492 | P790002 | 026 |
| 00812301020508 | P790002 | 026 |
| 00812301020515 | P790002 | 026 |
| 00812301020522 | P790002 | 026 |
| 00812301020539 | P790002 | 026 |
| 00812301020546 | P790002 | 026 |
| 00812301020577 | P790002 | 026 |
| 00812301020584 | P790002 | 026 |
| 00812301020591 | P790002 | 026 |
| 00812301020607 | P790002 | 026 |
| 00812301020645 | P790002 | 026 |
| 00812301020638 | P790002 | 026 |
| 00812301020621 | P790002 | 026 |
| 00812301020614 | P790002 | 026 |
| 00812301020478 | P790002 | 028 |
| 00812301020461 | P790002 | 028 |
| 00812301020454 | P790002 | 028 |
| 00812301020447 | P790002 | 028 |
| 00812301020676 | P790002 | 028 |
| 00812301020485 | P790002 | 028 |
| 00812301020553 | P790002 | 028 |
| 00812301020560 | P790002 | 028 |
| 00812301020652 | P790002 | 028 |
| 00812301020669 | P790002 | 028 |
| 00812301020430 | P790002 | 028 |