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CustomizedBone Service

by Fin-Ceramica Faenza S.P.A. 5 variants

510(k) K171507

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK171507 Date1 Sep 2017ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GXN
Device Class
Class II
Regulation
21 CFR Part 882.5330
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The CustomizedBone Service is a patient-specific, preformed cranioplasty plate designed for cranial reconstruction. It is constructed from hydroxyapatite, a biocompatible material with a porous structure that mimics human bone, providing structural support and integration with surrounding tissue.

This device is supplied as a single-use, non-alterable implant intended for use in neurosurgical settings. It is classified under FDA product code GXN as a Class II device with special controls, and its use is regulated under 21 CFR 882.5330. The implant is manufactured by Fin-Ceramica Faenza S.P.A. and requires sterile packaging for surgical application.

Other devices from Fin-Ceramica Faenza S.P.A.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the CustomizedBone Service used for in neurosurgical procedures?

    The CustomizedBone Service is designed specifically for cranial reconstruction after procedures such as craniectomy, where a section of the skull has been temporarily removed. Its patient-specific, preformed shape ensures a precise fit, providing structural support and integrating with surrounding bone tissue over time. The implant’s biocompatible hydroxyapatite material mimics natural bone, promoting long-term stability.

  • Is the CustomizedBone Service intended for reuse or is it single-use only?

    The CustomizedBone Service is explicitly supplied as a single-use implant. It is non-alterable and intended for one-time surgical application, ensuring sterility and safety for the patient. Reuse is not recommended or supported by the manufacturer.

  • How is the CustomizedBone Service packaged and prepared for surgical use?

    The CustomizedBone Service comes in sterile packaging, which is essential for surgical application. This ensures the implant is free from contamination before use in the operating room, meeting the requirements for clean surgical environments.

  • What regulatory pathway was followed for the FDA clearance of the CustomizedBone Service?

    The CustomizedBone Service received FDA clearance through a 510(k) submission, classified as Substantially Equivalent (SE) under the Neurology advisory committee (NE). The device falls under product code GXN and is regulated under 21 CFR 882.5330, confirming its status as a Class II medical device with special controls.

  • How does the material composition of the CustomizedBone Service benefit patients undergoing cranial reconstruction?

    The CustomizedBone Service is made from hydroxyapatite, a biocompatible material with a porous structure that closely resembles human bone. This design promotes osseointegration—the natural bonding of the implant with surrounding bone tissue—while providing structural support. The material is also designed to reduce the risk of rejection or adverse reactions, enhancing long-term stability.