DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3— 510(k) K014001

Substantially Equivalent

Oral Osteodistraction, L.P.

FDA 510(k) clearance K014001 for DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3, Substantially Equivalent on 2003-02-04. Applicant: Oral Osteodistraction, L.P..

Clearance details

Applicant: Oral Osteodistraction, L.P.
Product code: Code MQN
Advisory panel: Dental
Date received: 2001-12-04
Decision date: 2003-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Appollo Beach, FL, US

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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.