SafeOp 3: Neural Informatix System
FDA 510(k) K252842 · Alphatec Spine, Inc.
510(k) numberK252842
Submission
- Device name
- SafeOp 3: Neural Informatix System
- Applicant
- Alphatec Spine, Inc.
Carlsbad, CA, US - Received
- September 8, 2025
- Decision date
- January 11, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K212166 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressGWF · Traditional | Inomed Medizintechnik GmbH | 01/07/2022SE |
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Questions and answers
When was SafeOp 3: Neural Informatix System cleared by the FDA?
SafeOp 3: Neural Informatix System (K252842) received a 510(k) decision of Substantially Equivalent on January 11, 2026, 125 days after the submission was received.
What is the product code of K252842?
The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.