Cleared Traditional

CustomizedBone Service

K180513 · Fin-Ceramica Faenza S.P.A. · Neurology
May 2018
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K180513 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 May 15, 2018, 77 days after receiving the submission on February 27, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5330.

Submission Details

510(k) Number K180513 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 2018
Decision Date May 15, 2018
Days to Decision 77 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

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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