Cleared Traditional

CustomizedBone Service

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

About This 510(k) Submission

K171507 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 September 1, 2017, 101 days after receiving the submission on May 23, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5330.

Submission Details

510(k) Number K171507 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code GXN — Plate, Cranioplasty, Preformed, Non-alterable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5330

Similar Devices — GXN Plate, Cranioplasty, Preformed, Non-alterable

All 53
METICULY Patient-specific titanium mesh implant
K252958 · Meticuly Co., Ltd. · Jan 2026
Synthes Patient Specific Implants
K243715 · Synthes GmbH · Nov 2025
KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE
K252573 · KLS-Martin L.P. · Nov 2025
CustomizedBone Service
K240567 · Fin-Ceramica Faenza S.P.A. · Mar 2024
Longeviti ClearFit OTS Cranial Implant
K231920 · Longeviti Neuro Solutions, LLC · Nov 2023
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
K214109 · Kontour(Xi?An) Medical Technology Co., Ltd. · Oct 2022