To qualify and approve an alternate, proposed supplier to provide thermoformed petg packaging trays and lids utilized in the final sterile pack assembly of ebi osteogen surgically implantable bone growth stimulators and spf implantable spinal fusion stimulators.
| Device | SpF Implantable Spinal Fusion Stimulators |
| Generic Name | Stimulator, Invasive Bone Growth |
| Applicant | EBI, LLC |
| Date Received | 2021-01-21 |
| Decision Date | 2021-02-17 |
| PMA | P850035 |
| Supplement | S056 |
| 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 |
|---|
| P850035 | | Original Filing |
| S058 |
2022-10-28 |
30-day Notice |
| S057 |
2022-05-27 |
Real-time Process |
| S056 |
2021-01-21 |
30-day Notice |
| S055 |
2019-06-21 |
30-day Notice |
| S054 | | |
| S053 |
2018-04-09 |
30-day Notice |
| S052 |
2018-04-04 |
30-day Notice |
| S051 |
2018-04-02 |
135 Review Track For 30-day Notice |
| S050 |
2018-03-29 |
30-day Notice |
| S049 |
2018-03-09 |
30-day Notice |
| S048 |
2018-03-01 |
30-day Notice |
| S047 |
2018-02-21 |
30-day Notice |
| S046 |
2018-02-13 |
30-day Notice |
| S045 |
2017-05-04 |
30-day Notice |
| S044 |
2017-03-14 |
30-day Notice |
| S043 |
2016-10-31 |
Special (immediate Track) |
| S042 |
2016-02-19 |
Special (immediate Track) |
| S041 |
2015-12-17 |
30-day Notice |
| S040 |
2015-11-19 |
30-day Notice |
| S039 |
2015-10-08 |
30-day Notice |
| S038 |
2014-08-20 |
30-day Notice |
| S037 | | |
| S036 |
2013-09-06 |
30-day Notice |
| S035 |
2013-04-30 |
30-day Notice |
| S034 |
2012-02-01 |
30-day Notice |
| S033 |
2008-07-22 |
Normal 180 Day Track No User Fee |
| S032 |
2008-07-17 |
30-day Notice |
| S031 |
2007-02-23 |
Real-time Process |
| S030 |
2004-06-09 |
Normal 180 Day Track |
| S029 |
2002-06-13 |
Normal 180 Day Track |
| S028 |
2000-05-30 |
Real-time Process |
| S027 | | |
| S026 | | |
| S025 |
2000-03-31 |
Normal 180 Day Track |
| S024 |
1998-07-06 |
Normal 180 Day Track |
| S023 |
1998-04-09 |
Real-time Process |
| S022 |
1997-04-08 |
Real-time Process |
| S021 |
1996-10-17 |
Normal 180 Day Track |
| S020 |
1996-07-19 |
Normal 180 Day Track |
| S019 |
1996-03-13 |
Normal 180 Day Track |
| S018 |
1995-12-08 |
Special (immediate Track) |
| S017 |
1994-11-22 |
Normal 180 Day Track |
| S016 |
1994-11-15 |
Normal 180 Day Track |
| S015 | | |
| S014 | | |
| S013 |
1992-03-27 |
Normal 180 Day Track |
| S012 |
1991-05-10 |
Normal 180 Day Track |
| S011 | | |
| S010 |
1990-10-25 |
Normal 180 Day Track |
| S009 | | |
| S008 |
1990-05-31 |
Normal 180 Day Track |
| S007 |
1988-12-16 |
Normal 180 Day Track |
| S006 |
1988-10-12 |
Normal 180 Day Track |
| S005 |
1988-04-18 |
Normal 180 Day Track |
| S004 |
1988-03-16 |
Normal 180 Day Track |
| S003 |
1988-02-26 |
Normal 180 Day Track |
| S002 |
1988-01-15 |
Normal 180 Day Track |
| S001 | | |
NIH GUDID Devices