INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64 HOLE PLATES, MODELS PLT-1058 AND PLT-1059— 510(k) K051341

Name: FDA 510(k) clearance K051341
Creator: U.S. Food and Drug Administration
Published: 2005-05-27

Substantially Equivalent

Inion , Ltd.

FDA 510(k) clearance K051341 for INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64 HOLE PLATES, MODELS PLT-1058 AND PLT-1059, Substantially Equivalent on 2005-05-27. Applicant: Inion , Ltd.. Device class: 2.

Clearance details

Applicant: Inion , Ltd.
Product code: Code JEY
Device class: Class 2
Regulation: 21 CFR 872.4760
Advisory panel: Dental
Date received: 2005-05-23
Decision date: 2005-05-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Tampere, FI

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Adverse events under product code JEY

product code JEY

Injury: 1,542
Malfunction: 2,292
Total: 3,834

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.