PMA P210035S002
- Device
- AccelStim™
- Applicant
- Orthofix US, LLC
- PMA number
- P210035
- Supplement
- S002
- Product code
- LOF
- Decision date
- 2024-07-11
- Classification
- Orthopedic
- Generic name
- Stimulator, bone growth, non-invasive
- Approval order statement
- Approval for a modification of the previously approved positioning strap utilized to hold the AccelStim transducer in place at the treatment site.
Current openFDA PMA Record#
- Device
- AccelStim™
- Applicant
- Orthofix US, LLC
- PMA number
- P210035
- Supplement
- S002
- Product code
- LOF
- Generic name
- Stimulator, bone growth, non-invasive
- Decision date
- 2024-07-11
- Decision code
- APPR
- Date received
- 2024-04-12
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a modification of the previously approved positioning strap utilized to hold the AccelStim transducer in place at the treatment site.