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FDA 510(k)

SafeOp 3: Neural Informatix Systeem

K-Number: K234092 · 2024-04-19

ApplicantAlphatec Spine, Inc.
Decision Date2024-04-19
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SafeOp 3: Neural Informatix Systeem is a medical device manufactured by Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2024-04-19 under approval number K234092. 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 Systeem?

SafeOp 3: Neural Informatix Systeem is a medical device that received FDA 510(k) clearance on 2024-04-19. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K234092.

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

SafeOp 3: Neural Informatix Systeem received FDA 510(k) clearance on 2024-04-19, under approval number K234092.

What company makes SafeOp 3: Neural Informatix Systeem?

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

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

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

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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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