Cleared Traditional

CustomizedBone Service

K160707 · Fin-Ceramica Faenza S.P.A. · Neurology
Dec 2016
Decision
278d
Days
Class 2
Risk

About This 510(k) Submission

K160707 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 December 17, 2016, 278 days after receiving the submission on March 14, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5330.

Submission Details

510(k) Number K160707 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 2016
Decision Date December 17, 2016
Days to Decision 278 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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