Cleared Special

CustomizedBone Service

K240567 · Fin-Ceramica Faenza S.P.A. · Neurology
Mar 2024
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K240567 is an FDA 510(k) clearance for the CustomizedBone Service, a Plate, Cranioplasty, Preformed, Non-alterable (Class II — Special Controls, product code GXN), submitted by Fin-Ceramica Faenza S.P.A. (Faenza, IT). The FDA issued a Cleared decision on March 28, 2024, 28 days after receiving the submission on February 29, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5330.

Submission Details

510(k) Number K240567 FDA.gov
FDA Decision Cleared SESE
Date Received February 29, 2024
Decision Date March 28, 2024
Days to Decision 28 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXN — Plate, Cranioplasty, Preformed, Non-alterable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5330

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