Approval for three new coils: the flx 5, the xl coilette and the mini coilette and a modified version of the bone healing system model 2001 controller. The device, as modified, will be marketed under the trade name ebi bone healing system and is indicated for the treatment of fracture non-unions, failed fusions, and congenital pseudoarthroses in the appendicular system.
| Device | EBI BONE HEALING SYSTEM |
| Classification Name | Stimulator, Bone Growth, Non-invasive |
| Generic Name | Stimulator, Bone Growth, Non-invasive |
| Applicant | EBI, LLC |
| Date Received | 2005-06-17 |
| Decision Date | 2005-09-26 |
| PMA | P790002 |
| 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 | EBI, LLC 399 Jefferson Road parsippany, NJ 07054 |
Supplemental Filings
| 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 |
|
NIH GUDID Devices