- Device
- SpinalStim
- Applicant
- Orthofix, Inc.
- PMA number
- P850007
- Supplement
- S036
- Product code
- LOF
- Generic name
- Stimulator, bone growth, non-invasive
- Decision date
- 2017-06-22
- Decision code
- APPR
- Date received
- 2017-03-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- 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