PMA P850007S042
- Device
- SpinalStim
- Applicant
- Orthofix, Inc.
- PMA number
- P850007
- Supplement
- S042
- Product code
- LOF
- Decision date
- 2019-07-03
- Classification
- Stimulator, Bone Growth, Non-invasive
- Generic name
- Stimulator, bone growth, non-invasive
- Approval order statement
- Modification in the verification step for the coil winding procedure and to add equipment to cut and split the ribbon cable to the desired specifications.
Current openFDA PMA Record#
- Device
- SpinalStim
- Applicant
- Orthofix, Inc.
- PMA number
- P850007
- Supplement
- S042
- Product code
- LOF
- Generic name
- Stimulator, bone growth, non-invasive
- Decision date
- 2019-07-03
- Decision code
- OK30
- Date received
- 2019-06-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification in the verification step for the coil winding procedure and to add equipment to cut and split the ribbon cable to the desired specifications.