CervicalStim
FDA premarket approval P030034/S012 · decided 2018-08-22
Approval details
- PMA number
- P030034
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CervicalStim
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Orthofix, Inc.
- Date received
- 2018-05-24
- Decision date
- 2018-08-22
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lewisville, TX
- Statement
- Approval for two proposed alternate external power supply units for Orthofixs currently marketed CervicalStim (Model 5505), SpinalStim (Model 5212) and PhysioStim (Models 5302, 5303, 5313, 5314L, 5314R, 5315) non-invasive Bone Growth Stimulator devices.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.