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FDA 510(k)

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

K-Number: K240137 · 2024-02-16

ApplicantNeos Surgery S.L
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 the device name listed in this FDA 510(k) record. The listed applicant is Neos Surgery S.L. It received FDA 510(k) clearance on 2024-02-16 under 510(k) 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. The listed applicant is Neos Surgery S.L. The 510(k) number is K240137.

When did Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System receive FDA 510(k) clearance?

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

Who is the listed applicant for Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System?

The FDA 510(k) record lists Neos Surgery S.L as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Neos Surgery S.L as applicant

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Related Devices (Code: GXR)

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.

K253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc.K221606Absorbable Cranial Flap Fixation SystemChendu Medart Medical Scientific Co., Ltd.K192310Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd.K192162NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateNeurovention, LLCK181539OSSDSIGN CranioplugOssdsign ABK181382GuardianTM Burr Hole Cover SystemSt Jude Medical

Official Source

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

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