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 | CervicalStim® |
| Generic Name | Stimulator, Bone Growth, Non-invasive |
| Applicant | Orthofix, Inc.3451 Plano Parkwaylewisville, TX 75056 PMA NumberP030034 Supplement NumberS017 Date Received03/16/2022 Decision Date06/14/2022 Product Code LOF Advisory Committee Orthopedic Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
| Date Received | 2022-03-16 |
| Decision Date | 2022-06-14 |
| PMA | P030034 |
| Supplement | S017 |
| 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 PMA NumberP030034 Supplement NumberS017 Date Received03/16/2022 Decision Date06/14/2022 Product Code LOF Advisory Committee Orthopedic Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For Updates To Orthofix’s Currently Marketed "STIM OnTrack" Mobile Medical Application. |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 18257200078936 | P030034 | 006 |
| 18257200007158 | P030034 | 006 |
| 18257200007165 | P030034 | 006 |
| 18257200079094 | P030034 | 006 |
| 18257200079100 | P030034 | 006 |
| 18257200079131 | P030034 | 006 |
| 18257200080816 | P030034 | 006 |
| 18257200080823 | P030034 | 006 |
| 18257200123919 | P030034 | 009 |
| 18257200105663 | P030034 | 009 |
| 18257200123933 | P030034 | 009 |
| 18257200131440 | P030034 | 009 |
| 18257200105649 | P030034 | 009 |
| 18257200105632 | P030034 | 009 |
| 18257200105656 | P030034 | 009 |