PMA P850007S046
- Device
- PhysioStim®, SpinalStim®
- Applicant
- Orthofix, Inc.
- PMA number
- P850007
- Supplement
- S046
- Product code
- LOF
- Decision date
- 2022-06-14
- Generic name
- Stimulator, bone growth, non-invasive
- Approval order statement
- Approval for updates to Orthofixs currently marketed STIM onTrack mobile medical application.
Current openFDA PMA Record#
- Device
- PhysioStim®, SpinalStim®
- Applicant
- Orthofix, Inc.
- PMA number
- P850007
- Supplement
- S046
- Product code
- LOF
- Generic name
- Stimulator, bone growth, non-invasive
- Decision date
- 2022-06-14
- Decision code
- APPR
- Date received
- 2022-03-16
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for updates to Orthofixs currently marketed STIM onTrack mobile medical application.