This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | ORTHOPAK(R) BONE GROWTH STIMULATOR |
| Classification Name | Stimulator, Bone Growth, Non-invasive |
| Generic Name | Stimulator, Bone Growth, Non-invasive |
| Applicant | EBI, LLC |
| Date Received | 1987-08-04 |
| Decision Date | 1987-09-17 |
| PMA | P850022 |
| Supplement | S004 |
| Product Code | LOF |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | EBI, LLC 399 Jefferson Road parsippany, NJ 07054 |
| 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) |
| Device ID | PMA | Supp |
|---|---|---|
| 00812301020188 | P850022 | 006 |
| 00880304820845 | P850022 | 006 |
| 00880304820852 | P850022 | 006 |
| 00812301020201 | P850022 | 008 |
| 00812301020195 | P850022 | 008 |
| 00812301020249 | P850022 | 017 |
| 00812301020232 | P850022 | 017 |
| 00812301020225 | P850022 | 017 |
| 00812301020218 | P850022 | 017 |
| 00812301020416 | P850022 | 017 |
| 00887868269318 | P850022 | 017 |
| 00887868269301 | P850022 | 017 |
| 00887868269295 | P850022 | 017 |
| 00887868269288 | P850022 | 017 |
| 00887868269271 | P850022 | 017 |
| 00812301020256 | P850022 | 017 |
| 00812301020263 | P850022 | 017 |
| 00812301020409 | P850022 | 017 |
| 00812301020393 | P850022 | 017 |
| 00812301020386 | P850022 | 017 |
| 00812301020379 | P850022 | 017 |
| 00812301020362 | P850022 | 017 |
| 00812301020355 | P850022 | 017 |
| 00812301020348 | P850022 | 017 |
| 00812301020331 | P850022 | 017 |
| 00812301020324 | P850022 | 017 |
| 00812301020317 | P850022 | 017 |
| 00812301020300 | P850022 | 017 |
| 00812301020294 | P850022 | 017 |
| 00812301020287 | P850022 | 017 |
| 00812301020270 | P850022 | 017 |
| 00887868269264 | P850022 | 017 |