Approval for design modifications to the garment covering, the treatment coils, liquid crystal display, control unit housing profile, orientation of the controls, software/ firmware, power supply cord, and labeling. The device, as modified, will be marketed under the trade name cervical-stim and is indicated as an adjunct to cervical fusion surgery in patients at high risk for non-fushion.
| Device | CERVICAL-STIM CERVICAL FUSION SYSTEM |
| Classification Name | Stimulator, Bone Growth, Non-invasive |
| Generic Name | Stimulator, Bone Growth, Non-invasive |
| Applicant | Orthofix, Inc. |
| Date Received | 2011-01-19 |
| Decision Date | 2011-03-11 |
| PMA | P030034 |
| Supplement | S005 |
| 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