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 OrthoPak Non-invasive Bone Growth Stimulator System; Biomet SpinalPak Non-invasive Spine Fusion Stimulator 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 | P850022 |
| Supplement | S029 |
| Product Code | LOF |
| 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 | 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 |
|---|
| P850022 | | Original Filing |
| S031 |
2022-10-28 |
30-day Notice |
| S030 |
2019-09-10 |
Real-time Process |
| S029 |
2018-03-01 |
30-day Notice |
| S028 |
2016-11-08 |
30-day Notice |
| S027 |
2015-12-17 |
30-day Notice |
| S026 |
2015-10-08 |
30-day Notice |
| S025 |
2015-08-10 |
30-day Notice |
| S024 |
2015-04-24 |
Real-time Process |
| S023 |
2014-08-04 |
30-day Notice |
| S022 |
2014-04-10 |
30-day Notice |
| S021 |
2014-02-24 |
30-day Notice |
| S020 |
2013-08-13 |
Special (immediate Track) |
| S019 | | |
| S018 |
2011-06-13 |
Real-time Process |
| S017 |
2009-09-16 |
Normal 180 Day Track |
| S016 |
2006-02-06 |
Normal 180 Day Track |
| S015 |
2003-09-30 |
Normal 180 Day Track |
| S014 |
2003-04-23 |
Special (immediate Track) |
| S013 |
2001-06-11 |
Normal 180 Day Track |
| S012 |
1999-07-09 |
Real-time Process |
| S011 |
1998-06-18 |
Real-time Process |
| S010 | | |
| S009 |
1997-03-13 |
Panel Track |
| S008 |
1992-10-05 |
Normal 180 Day Track |
| S007 |
1992-09-24 |
Normal 180 Day Track |
| S006 |
1989-08-25 |
Normal 180 Day Track |
| S005 |
1989-01-26 |
Normal 180 Day Track |
| S004 |
1987-08-04 |
Normal 180 Day Track |
| S003 |
1986-11-17 |
Special (immediate Track) |
| S002 | | |
| S001 |
1986-09-16 |
Special (immediate Track) |
NIH GUDID Devices