Approval for implementation of an additional finished device cleaning process and associated new, semi- automated, plc cleaning equipment to further ensure adequate removal of manufacturing materials and residue from finished devices has occurred through conformance to cleanliness requirements in accordance with zimmer biomet ges 09802 implant residual materials and endotoxin limits.
| Device | EBI OsteoGen Implantable Bone Growth Stimulators |
| Classification Name | Stimulator, Invasive Bone Growth |
| Generic Name | Stimulator, Invasive Bone Growth |
| Applicant | EBI, LLC |
| Date Received | 2018-04-02 |
| Decision Date | 2018-11-02 |
| PMA | P790005 |
| Supplement | S062 |
| Product Code | LOE |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Orthopedic |
| Supplement Type | 135 Review Track For 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