OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM— 510(k) K043434

Name: FDA 510(k) clearance K043434
Creator: U.S. Food and Drug Administration
Published: 2005-02-10

Substantially Equivalent

Osteomed LP

FDA 510(k) clearance K043434 for OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, Substantially Equivalent on 2005-02-10. Applicant: Osteomed LP. Device class: 2.

Clearance details

Applicant: Osteomed LP
Product code: Code MQN
Device class: Class 2
Regulation: 21 CFR 872.4760
Advisory panel: Dental
Date received: 2004-12-13
Decision date: 2005-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Addison, TX, 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.