FDA 510(k)

Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System

K-Number: K240137 · 2024-02-16

Decision Date2024-02-16

Product CodeGXR

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System is a medical device manufactured by Neos Surgery S.L. It received FDA 510(k) clearance on 2024-02-16 under approval number K240137. The device is classified under product code GXR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System?

Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System is a medical device that received FDA 510(k) clearance on 2024-02-16. It is manufactured by Neos Surgery S.L. The 510(k) number is K240137.

When was Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System approved by the FDA?

Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System received FDA 510(k) clearance on 2024-02-16, under approval number K240137.

What company makes Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System?

Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System is manufactured by Neos Surgery S.L.

What is the FDA product code for Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System?

The FDA product code for Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System is GXR.

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Other Devices by Neos Surgery S.L

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Related Devices (Code: GXR)

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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.