Approval for a modified version of the bioelectron spinalpak fusion stimulator. The modifications are: 1) the current spinalpak is powered by 1 alkaline 9 volt battery that must be replaced daily. The modified version will be powered by 1 nimn "aa" rechargeable cell. The charger will be included. 2) the housing has been modified to accommodate for a rechargeable battery and an lcd display. The current spinalpak has an led display. The modified version will have a 6 message lcd display. 3) the pcb circuitry has been modified to accommodate the lcd display and the rechargeable battery pack. 4) the original software was written in assembly code. The modified version was rewritten in c. The device, as modified, will be marketed under the trade name bioelectron spinalpak ii spine fusion stimulator and is indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels.
| Device | BIOELECTRON SPINALPAK II SPINE FUSION STIMULATOR |
| Classification Name | Stimulator, Bone Growth, Non-invasive |
| Generic Name | Stimulator, Bone Growth, Non-invasive |
| Applicant | EBI, LLC |
| Date Received | 2003-09-30 |
| Decision Date | 2004-01-12 |
| PMA | P850022 |
| Supplement | S015 |
| Product Code | LOF |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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