Cleared Traditional

K171507 - CustomizedBone Service

K171507 is an FDA 510(k) clearance for CustomizedBone Service, manufactured by Fin-Ceramica Faenza S.P.A.. The device is a Class 2 Neurology device with product code GXN cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K171507 · Fin-Ceramica Faenza S.P.A. · Neurology device
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Sep 2017
Decision
101d
Days
Class 2
Risk

K171507 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 September 1, 2017 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5330 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

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

FDA 510(k) Submission Details - K171507

510(k) Number K171507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2017
Decision Date September 01, 2017
Days to Decision 101 days
Submission Type Traditional
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
48d faster than avg
Panel avg: 149d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXN Device Classification - Class 2, Special Controls

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 56
Devices cleared under the same product code (GXN) and FDA review panel - the closest regulatory comparables to K171507.
OsteoFab Patient Specific Cranial Device
K180064 · Oxford Performance Materials, Inc. · Jul 2018
CustomizedBone Service
K180513 · Fin-Ceramica Faenza S.P.A. · May 2018
Longeviti PMMA Static Cranial Implant
K170410 · Longeviti Neuro Solutions, LLC · Mar 2018
Cranial PSI
K161090 · Ossdsign AB · Jan 2017
CustomizedBone Service
K160707 · Fin-Ceramica Faenza S.P.A. · Dec 2016
BioArchitects Patient Specific Cranial/Craniofacial Plate
K151692 · Bioarchitects USA, LLC · Nov 2015