Approval for software and firmware updates to the spinalstim and cervicalstim devices. The updates made are identical to both devices, and include modifications to the user display and mobile medical phone application
| Device | CervicalStim |
| Classification Name | Stimulator, Bone Growth, Non-invasive |
| Generic Name | Stimulator, Bone Growth, Non-invasive |
| Applicant | Orthofix, Inc. |
| Date Received | 2017-03-24 |
| Decision Date | 2017-06-22 |
| PMA | P030034 |
| Supplement | S010 |
| Product Code | LOF |
| 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