- Device
- PhysioStim and SpinalStim
- Applicant
- Orthofix, Inc.
- PMA number
- P850007
- Supplement
- S041
- Product code
- LOF
- Generic name
- Stimulator, bone growth, non-invasive
- Decision date
- 2019-06-18
- Decision code
- APPR
- Date received
- 2019-04-15
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for software and firmware updates to the SpinalStim. CervicalStim, and PhysioStim devices. The updates made are identical to each devices, and include modifications to the mobile medical phone application