CustomizedBone Service— 510(k) K171507

Name: FDA 510(k) clearance K171507
Creator: U.S. Food and Drug Administration
Published: 2017-09-01

Substantially Equivalent

Fin-Ceramica Faenza S.P.A.

FDA 510(k) clearance K171507 for CustomizedBone Service, Substantially Equivalent on 2017-09-01. Applicant: Fin-Ceramica Faenza S.P.A.. Device class: 2.

Clearance details

Applicant: Fin-Ceramica Faenza S.P.A.
Product code: Code GXN
Device class: Class 2
Regulation: 21 CFR 882.5330
Advisory panel: Neurology
Date received: 2017-05-23
Decision date: 2017-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Faenza, IT

Download summary PDF View on FDA.gov ↗

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K240567 — CustomizedBone Service2024-03-28
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K160707 — CustomizedBone Service2016-12-17

Adverse events under product code GXN

product code GXN

Injury: 208
Total: 208

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.