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FDA 510(k)

SafeOp 2: Neural Informatix System

K-Number: K213849 · 2022-03-09

ApplicantAlphatec Spine, Inc.
Decision Date2022-03-09
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SafeOp 2: Neural Informatix System is a medical device manufactured by Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2022-03-09 under approval number K213849. 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 2: Neural Informatix System?

SafeOp 2: Neural Informatix System is a medical device that received FDA 510(k) clearance on 2022-03-09. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K213849.

When was SafeOp 2: Neural Informatix System approved by the FDA?

SafeOp 2: Neural Informatix System received FDA 510(k) clearance on 2022-03-09, under approval number K213849.

What company makes SafeOp 2: Neural Informatix System?

SafeOp 2: Neural Informatix System is manufactured by Alphatec Spine, Inc..

What is the FDA product code for SafeOp 2: Neural Informatix System?

The FDA product code for SafeOp 2: Neural Informatix System is GWF.

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Related PubMed Literature

PMID: 40077817 Research Progress on Neural Cell Culture Systems. Current neuropharmacology (2025)

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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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