The actastim-s spine fusion stimulator is a noninvasive bone growth stimulator indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels. The device is rx only, and intended for single patient use in adult patients only.
| Device | ActaStim-S Spine Fusion Stimulator |
| Generic Name | Stimulator, Bone Growth, Non-invasive |
| Applicant | Theragen, Inc. |
| Date Received | 2019-11-18 |
| Decision Date | 2020-12-09 |
| PMA | P190030 |
| Supplement | S |
| Product Code | LOF |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Theragen, Inc. 11220 Assett Loop suite 101 manassas, VA 20109 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P190030 | | Original Filing |
| S001 |
2022-04-08 |
Real-time Process |
NIH GUDID Devices