Cleared Special

K193547 - CustomizedBone Service (FDA 510(k) Clearance)

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K193547 · Fin-Ceramica Faenza S.P.A. · Neurology device
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Jan 2020
Decision
28d
Days
Class 2
Risk

K193547 is an FDA 510(k) clearance for the CustomizedBone Service. Classified as Plate, Cranioplasty, Preformed, Non-alterable (product code GXN), Class II - Special Controls.

Submitted by Fin-Ceramica Faenza S.P.A. (Faenza, IT). The FDA issued a Cleared decision on January 17, 2020 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5330 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Fin-Ceramica Faenza S.P.A. devices

Submission Details

510(k) Number K193547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2019
Decision Date January 17, 2020
Days to Decision 28 days
Submission Type Special
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 148d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GXN Plate, Cranioplasty, Preformed, Non-alterable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5330
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GXN Plate, Cranioplasty, Preformed, Non-alterable

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