PMA P030034S013
- Device
- CervicalStim
- Applicant
- Orthofix, Inc.
- PMA number
- P030034
- Supplement
- S013
- Product code
- LOF
- Decision date
- 2018-12-20
- Classification
- Stimulator, Bone Growth, Non-invasive
- Generic name
- Stimulator, bone growth, non-invasive
- Approval order statement
- Approval for the addition of two alternative external power supply units.
Current openFDA PMA Record#
- Device
- CervicalStim
- Applicant
- Orthofix, Inc.
- PMA number
- P030034
- Supplement
- S013
- Product code
- LOF
- Generic name
- Stimulator, bone growth, non-invasive
- Decision date
- 2018-12-20
- Decision code
- APPR
- Date received
- 2018-09-27
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the addition of two alternative external power supply units.