K252842
- 510(k) number
- K252842
- Device name
- SafeOp 3: Neural Informatix System
- Applicant
- Alphatec Spine, Inc. CA · US
- Product code
- GWF — Stimulator, Electrical, Evoked Response
- Decision date
- 2026-01-11
- Date received
- 2025-09-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K252842.pdf
Official FDA record: K252842
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.