Approval for updates to the stim ontrack mobile application for compatibility with android os. The optional mobile application is identical in functionality to the previously approved ios version. The application is compatible with the cervicalstim model 5505, spinalstim model 5212, and physiostim models 5302, 5303, 5313, 5314, and 5315.
| Device | CervicalStim |
| Classification Name | Stimulator, Bone Growth, Non-invasive |
| Generic Name | Stimulator, Bone Growth, Non-invasive |
| Applicant | Orthofix, Inc. |
| Date Received | 2017-12-07 |
| Decision Date | 2018-03-07 |
| PMA | P030034 |
| Supplement | S011 |
| 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 | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Orthofix, Inc. 3451 Plano Parkway lewisville, TX 75056 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P030034 | | Original Filing |
| S017 |
2022-03-16 |
Real-time Process |
| S016 | | |
| S015 |
2019-09-16 |
30-day Notice |
| S014 |
2019-04-15 |
Real-time Process |
| S013 |
2018-09-27 |
Real-time Process |
| S012 |
2018-05-24 |
Real-time Process |
| S011 |
2017-12-07 |
Real-time Process |
| S010 |
2017-03-24 |
Real-time Process |
| S009 |
2016-07-05 |
Normal 180 Day Track |
| S008 |
2015-07-28 |
30-day Notice |
| S007 |
2014-08-01 |
30-day Notice |
| S006 |
2011-10-03 |
30-day Notice |
| S005 |
2011-01-19 |
Real-time Process |
| S004 |
2010-01-21 |
Normal 180 Day Track No User Fee |
| S003 |
2009-08-04 |
30-day Notice |
| S002 |
2009-05-07 |
Real-time Process |
| S001 |
2005-02-14 |
Real-time Process |
NIH GUDID Devices