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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 the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2026-01-11 under 510(k) 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. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K252842.

When did SafeOp 3: Neural Informatix System receive FDA 510(k) clearance?

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

Who is the listed applicant for SafeOp 3: Neural Informatix System?

The FDA 510(k) record lists Alphatec Spine, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Alphatec Spine, Inc. as applicant

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Related Devices (Code: GWF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253301BraiN20® (BraiN20)Time IS Brain, S.L.K243982Nicolet EDXNatus Neurology IncorporatedK243495Natus Ultrapro S100 (982A0594)Natus Neurology IncorporatedK242345Delphi StimulatorQuantalx NeuroscienceK234092SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc.K234080MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)Soterix Medical, Inc.

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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