FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS— 510(k) K091812

Substantially Equivalent

Frontier Devices, Inc.

FDA 510(k) clearance K091812 for FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS, Substantially Equivalent on 2010-05-07. Applicant: Frontier Devices, Inc..

Clearance details

Applicant: Frontier Devices, Inc.
Product code: Code JEY
Advisory panel: Dental
Date received: 2009-06-18
Decision date: 2010-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pelham, AL, 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.