ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5)— 510(k) K042278

Name: FDA 510(k) clearance K042278
Creator: U.S. Food and Drug Administration
Published: 2005-01-28

Substantially Equivalent

Oral Osteodistraction, L.P.

FDA 510(k) clearance K042278 for ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5), Substantially Equivalent on 2005-01-28. Applicant: Oral Osteodistraction, L.P.. Device class: 2.

Clearance details

Applicant: Oral Osteodistraction, L.P.
Product code: Code MQN
Device class: Class 2
Regulation: 21 CFR 872.4760
Advisory panel: Dental
Date received: 2004-08-23
Decision date: 2005-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Appollo Beach, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MQN

product code MQN

Injury: 346
Total: 346

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.