Approval for manufacturing changes involving the verification of alcohol sterility and the magnet overriding test fixture.
| Device | ORTHOGEN/OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATOR |
| Classification Name | Stimulator, Invasive Bone Growth |
| Generic Name | Stimulator, Invasive Bone Growth |
| Applicant | EBI, LLC |
| Date Received | 2011-04-08 |
| Decision Date | 2011-05-06 |
| PMA | P790005 |
| Supplement | S047 |
| Product Code | LOE |
| Advisory Committee | Orthopedic |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | EBI, LLC 399 Jefferson Road parsippany, NJ 07054 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P790005 | | Original Filing |
| S069 |
2022-10-28 |
30-day Notice |
| S068 |
2022-05-27 |
Real-time Process |
| S067 |
2021-01-21 |
30-day Notice |
| S066 |
2019-06-21 |
30-day Notice |
| S065 | | |
| S064 |
2018-04-09 |
30-day Notice |
| S063 |
2018-04-04 |
30-day Notice |
| S062 |
2018-04-02 |
135 Review Track For 30-day Notice |
| S061 |
2018-03-29 |
30-day Notice |
| S060 |
2018-03-09 |
30-day Notice |
| S059 |
2018-03-01 |
30-day Notice |
| S058 |
2018-02-21 |
30-day Notice |
| S057 |
2018-02-13 |
30-day Notice |
| S056 |
2017-05-04 |
30-day Notice |
| S055 |
2017-03-14 |
30-day Notice |
| S054 |
2015-12-17 |
30-day Notice |
| S053 |
2015-11-19 |
30-day Notice |
| S052 |
2015-10-08 |
30-day Notice |
| S051 |
2014-08-20 |
30-day Notice |
| S050 |
2013-09-06 |
30-day Notice |
| S049 |
2013-04-30 |
30-day Notice |
| S048 |
2011-12-21 |
30-day Notice |
| S047 |
2011-04-08 |
Special (immediate Track) |
| S046 | | |
| S045 |
2008-07-17 |
30-day Notice |
| S044 |
2004-06-09 |
Normal 180 Day Track |
| S043 |
2000-05-30 |
Real-time Process |
| S042 |
2000-04-11 |
Real-time Process |
| S041 |
1998-06-24 |
Real-time Process |
| S040 |
1998-04-09 |
Real-time Process |
| S039 |
1996-10-17 |
Normal 180 Day Track |
| S038 |
1996-03-13 |
Normal 180 Day Track |
| S037 |
1994-11-15 |
Normal 180 Day Track |
| S036 | | |
| S035 |
1990-08-27 |
Normal 180 Day Track |
| S034 |
1990-01-26 |
Normal 180 Day Track |
| S033 |
1989-03-22 |
Normal 180 Day Track |
| S032 |
1988-03-16 |
Normal 180 Day Track |
| S031 |
1988-02-26 |
Normal 180 Day Track |
| S030 |
1987-06-10 |
Normal 180 Day Track |
| S029 |
1986-11-07 |
Normal 180 Day Track |
| S028 |
1985-10-30 |
|
| S027 |
1985-09-06 |
|
| S026 |
1985-06-13 |
|
| S025 |
1983-11-28 |
|
| S024 |
1983-10-04 |
|
| S023 |
1983-09-21 |
|
| S022 |
1983-08-31 |
|
| S021 |
1983-07-20 |
|
| S020 | | |
| S019 | | |
| S018 | | |
| S017 | | |
| S016 |
1983-03-07 |
|
| S015 | | |
| S014 | | |
| S013 |
1982-04-13 |
|
| S012 |
1982-03-08 |
|
| S011 |
1982-03-03 |
|
| S010 |
1981-09-24 |
|
| S009 |
1981-07-29 |
|
| S008 | | |
| S007 |
1981-05-22 |
|
| S006 |
1981-04-06 |
|
| S005 | | |
| S004 |
1980-12-16 |
Normal 180 Day Track |
| S003 |
1980-10-27 |
|
| S002 | | |
| S001 | | |
NIH GUDID Devices