CMS CRANIO MAXILLO FACIAL TITANIUM IMPLANT SYSTEM— 510(k) K951691

Substantially Equivalent

Medicon EG

FDA 510(k) clearance K951691 for CMS CRANIO MAXILLO FACIAL TITANIUM IMPLANT SYSTEM, Substantially Equivalent on 1995-07-26. Applicant: Medicon EG.

Clearance details

Applicant: Medicon EG
Product code: Code JEY
Advisory panel: Dental
Date received: 1995-04-05
Decision date: 1995-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Black Diamond, WA, US

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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.