FDA 510(k)

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

Número K: K240137 · 2024-02-16

Data da decisão2024-02-16

Código do produtoGXR

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Fonte oficial

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