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FDA 510(k)

SafeOp 3: Neural Informatix System

K-Number: K252842 · 2026-01-11

ApplicantAlphatec Spine, Inc.
Decision Date2026-01-11
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SafeOp 3: Neural Informatix System is a medical device manufactured by Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2026-01-11 under approval number K252842. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SafeOp 3: Neural Informatix System?

SafeOp 3: Neural Informatix System is a medical device that received FDA 510(k) clearance on 2026-01-11. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K252842.

When was SafeOp 3: Neural Informatix System approved by the FDA?

SafeOp 3: Neural Informatix System received FDA 510(k) clearance on 2026-01-11, under approval number K252842.

What company makes SafeOp 3: Neural Informatix System?

SafeOp 3: Neural Informatix System is manufactured by Alphatec Spine, Inc..

What is the FDA product code for SafeOp 3: Neural Informatix System?

The FDA product code for SafeOp 3: Neural Informatix System is GWF.

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Related PubMed Literature

PMID: 37288633 [Roadmap of Medical Device for Implanted Brain-computer Interface]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2023) PMID: 31472187 A translational framework for peripheral nerve stimulating electrodes: Reviewing the journey from concept to clinic. Journal of neuroscience methods (2019)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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