Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System— 510(k) K240137

Name: FDA 510(k) clearance K240137
Creator: U.S. Food and Drug Administration
Published: 2024-02-16

Substantially Equivalent

Neos Surgery S.L

FDA 510(k) clearance K240137 for Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System, Substantially Equivalent on 2024-02-16. Applicant: Neos Surgery S.L. Device class: 2.

Clearance details

Applicant: Neos Surgery S.L
Product code: Code GXR
Device class: Class 2
Regulation: 21 CFR 882.5250
Advisory panel: Neurology
Date received: 2024-01-18
Decision date: 2024-02-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Cerdanyola, ES

Download summary PDF View on FDA.gov ↗

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