PMA P850007S044
- Device
- SpinalStim
- Applicant
- Orthofix, Inc.
- PMA number
- P850007
- Supplement
- S044
- Product code
- LOF
- Decision date
- 2020-03-27
- Generic name
- Stimulator, bone growth, non-invasive
- Approval order statement
- Implementing an alternative machine to produce the device’s transducer coil.
Current openFDA PMA Record#
- Device
- SpinalStim
- Applicant
- Orthofix, Inc.
- PMA number
- P850007
- Supplement
- S044
- Product code
- LOF
- Generic name
- Stimulator, bone growth, non-invasive
- Decision date
- 2020-03-27
- Decision code
- OK30
- Date received
- 2020-02-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementing an alternative machine to produce the device’s transducer coil.