Qualification of an alternate-secondary, contract service provider to provide calibration, maintenance, and rental services of instrumentation and equipment used during qualification and validation activities for the ebi osteogen implantable gone growth stimulators, spf implantable spinal fusion stimulators, biomet ebi bone healing system, biomet spinalpak, and the biomet orthopak.
| Device | Biomet EBI Bone Healing System |
| Classification Name | Stimulator, Bone Growth, Non-invasive |
| Generic Name | Stimulator, Bone Growth, Non-invasive |
| Applicant | EBI, LLC |
| Date Received | 2018-03-01 |
| Decision Date | 2018-03-30 |
| PMA | P790002 |
| Supplement | S037 |
| Product Code | LOF |
| 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 |
|---|
| 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