Cleared Special

CustomizedBone Service

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

About This 510(k) Submission

K193547 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 January 17, 2020, 28 days after receiving the submission on December 20, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5330.

Submission Details

510(k) Number K193547 FDA.gov
FDA Decision Cleared 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

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