K234092
- 510(k) number
- K234092
- Device name
- SafeOp 3: Neural Informatix Systeem
- Applicant
- Alphatec Spine, Inc. CA · US
- Product code
- GWF — Stimulator, Electrical, Evoked Response
- Decision date
- 2024-04-19
- Date received
- 2023-12-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K234092.pdf
Official FDA record: K234092
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.