Addition of an alternate supplier to provide clean room contract certification services and high efficiency particulate air (hepa) filter distribution services for both the spf implantable spinal fusion system and the ebi osteogen implantable bone growth stimulator.
| Device | EBI OsteoGen Implantable Bone Growth Stimulators |
| Classification Name | Stimulator, Invasive Bone Growth |
| Generic Name | Stimulator, Invasive Bone Growth |
| Applicant | EBI, LLC |
| Date Received | 2018-02-21 |
| Decision Date | 2018-03-14 |
| PMA | P790005 |
| Supplement | S058 |
| Product Code | LOE |
| Advisory Committee | Orthopedic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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