Cleared Special

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

K240137 · Neos Surgery S.L · Neurology
Feb 2024
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K240137 is an FDA 510(k) clearance for the Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System, a Cover, Burr Hole (Class II — Special Controls, product code GXR), submitted by Neos Surgery S.L (Cerdanyola, ES). The FDA issued a Cleared decision on February 16, 2024, 29 days after receiving the submission on January 18, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5250.

Submission Details

510(k) Number K240137 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 2024
Decision Date February 16, 2024
Days to Decision 29 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXR — Cover, Burr Hole
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5250

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