510(k) K252842 ยท GWF Stimulator, Electrical, Evoked Response
SafeOp 3: Neural Informatix System
| Applicant | Alphatec Spine, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Jan 11, 2026 |
| Received | Sep 8, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252842
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2026 | Alphatec Spine, Inc. SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System Open, Classified |
GWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.