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 | Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System and Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator |
| Generic Name | Stimulator, Bone Growth, Non-invasive |
| Applicant | EBI, LLC1 Gatehall Drivesuite 303parsippany, NJ 07054 PMA NumberP850022 Supplement NumberS031 Date Received10/28/2022 Decision Date11/23/2022 Product Code LOF Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-10-28 |
| Decision Date | 2022-11-23 |
| PMA | P850022 |
| Supplement | S031 |
| 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 1 Gatehall Drive suite 303 parsippany, NJ 07054 PMA NumberP850022 Supplement NumberS031 Date Received10/28/2022 Decision Date11/23/2022 Product Code LOF Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement To Qualify An Alternate Contract Service Provider To Provide Calibration Services For Instrumentation And Lab Equipment Utilized To Support Manufacturing And Quality Operations. |
| 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 |