Cleared Traditional

K180513 - CustomizedBone Service (FDA 510(k) Clearance)

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

K180513 is an FDA 510(k) clearance for the CustomizedBone Service. This device is classified as 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 FDA review panel. Regulated under 21 CFR 882.5330.

Submission Details

510(k) Number K180513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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