Cleared Special

CustomizedBone Service (K193547) - 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
Combination Product No
PCCP Authorized No
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 Consultant

Regulatory and Clinical Research Institute, Inc.
Mary Beth Henderson

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 24
Devices cleared under the same product code (GXN) and FDA review panel - the closest regulatory comparables to K193547.
Longeviti ClearFit Cranial Implant
K203349 · Longeviti Neuro Solutions, LLC · Dec 2020
Longeviti ClearFit Cranial Implant
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DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional
K192702 · Synthes USA Products, LLC · Sep 2020
Longeviti ClearFit Cranial Implant
K191210 · Longeviti Neuro Solutions, LLC · Jan 2020
OsteoFab Patient Specific Cranial Device
K180064 · Oxford Performance Materials, Inc. · Jul 2018
CustomizedBone Service
K180513 · Fin-Ceramica Faenza S.P.A. · May 2018