510(k) Report

FDA applicant

Fin-Ceramica Faenza S.P.A.

Faenza, IT5 decisions2016–20240 recalls

FDA records 5 decisions for Fin-Ceramica Faenza S.P.A. (Faenza, IT) from 2016 to 2024: 5 510(k) clearances. All are in product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Fin-Ceramica Faenza S.P.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2016: 12017: 12018: 12020: 12024: 1
2016high 1 (2016) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Fin-Ceramica Faenza S.P.A. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GXNPlate, Cranioplasty, Preformed, Non-Alterable5decisions

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K193547CustomizedBone ServiceFin-Ceramica Faenza S.P.A. · 20201cites it

What has FDA decided for it lately?

  • K240567CustomizedBone ServiceFin-Ceramica Faenza S.P.A. · 2024
  • K193547CustomizedBone ServiceFin-Ceramica Faenza S.P.A. · 2020
  • K180513CustomizedBone ServiceFin-Ceramica Faenza S.P.A. · 2018
  • K171507CustomizedBone ServiceFin-Ceramica Faenza S.P.A. · 2017
  • K160707CustomizedBone ServiceFin-Ceramica Faenza S.P.A. · 2016

All 5 as Fin-Ceramica Faenza S.P.A. →