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.
October 8, 2019the center for devices and radiological health (cdrh) of the food and drug administration (fda) has evaluated your 30-day notice. The 30-day notice requested to modify the manufacturing process for sewing the garment assembly for the orthofix spinalstim model 5212 and modify the manufacturing process to cut, split, and strip the ribbon cable for the orthofix cervicalstim model 5505 and orthofix physiostim models 53xx. Based on the information submitted, fda has determined that submission of a 135-day pma supplement is not required. Therefore, you may distribute your device, incorporating the change described above, upon receipt of this email notification. If you have any questions, please contact the lead reviewer assigned to your submission, habacuc barrera.
| Device | PhysioStim and SpinalStim |
| Classification Name | Stimulator, Bone Growth, Non-invasive |
| Generic Name | Stimulator, Bone Growth, Non-invasive |
| Applicant | Orthofix, Inc. |
| Date Received | 2019-09-16 |
| Decision Date | 2019-10-08 |
| PMA | P850007 |
| Supplement | S043 |
| 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 | Orthofix, Inc. 3451 Plano Parkway lewisville, TX 75056 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850007 | Original Filing | |
| S046 | 2022-03-16 | Real-time Process |
| S045 | ||
| S044 | 2020-02-26 | 30-day Notice |
| S043 | 2019-09-16 | 30-day Notice |
| S042 | 2019-06-07 | 30-day Notice |
| S041 | 2019-04-15 | Real-time Process |
| S040 | 2018-09-27 | Real-time Process |
| S039 | 2018-05-24 | Real-time Process |
| S038 | 2017-12-07 | Real-time Process |
| S037 | 2017-08-15 | Normal 180 Day Track |
| S036 | 2017-03-24 | Real-time Process |
| S035 | 2016-07-05 | Normal 180 Day Track |
| S034 | 2015-07-28 | 30-day Notice |
| S033 | 2014-08-01 | 30-day Notice |
| S032 | 2011-10-03 | 30-day Notice |
| S031 | 2011-01-19 | Real-time Process |
| S030 | 2010-01-21 | Normal 180 Day Track No User Fee |
| S029 | 2009-08-04 | 30-day Notice |
| S028 | 2009-05-07 | Real-time Process |
| S027 | 2003-06-04 | Normal 180 Day Track |
| S026 | 2001-02-01 | Normal 180 Day Track |
| S025 | 2000-03-13 | Normal 180 Day Track |
| S024 | 1998-09-22 | Real-time Process |
| S023 | 1998-07-21 | Real-time Process |
| S022 | 1998-06-24 | Real-time Process |
| S021 | 1998-03-03 | Normal 180 Day Track |
| S020 | 1997-08-25 | Normal 180 Day Track |
| S019 | 1996-06-12 | Normal 180 Day Track |
| S018 | 1996-05-07 | Normal 180 Day Track |
| S017 | 1995-06-16 | Normal 180 Day Track |
| S016 | 1995-04-05 | Normal 180 Day Track |
| S015 | ||
| S014 | 1994-03-03 | Normal 180 Day Track |
| S013 | 1992-06-23 | Normal 180 Day Track |
| S012 | 1991-02-21 | Normal 180 Day Track |
| S011 | 1990-11-26 | Normal 180 Day Track |
| S010 | 1990-11-13 | Normal 180 Day Track |
| S009 | ||
| S008 | 1989-11-22 | Normal 180 Day Track |
| S007 | 1989-01-24 | Normal 180 Day Track |
| S006 | 1988-06-06 | Panel Track |
| S005 | 1988-01-28 | Normal 180 Day Track |
| S004 | 1987-08-05 | Normal 180 Day Track |
| S003 | 1987-06-17 | Normal 180 Day Track |
| S002 | 1986-12-10 | Normal 180 Day Track |
| S001 | 1986-06-30 | Normal 180 Day Track |