OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEM— 510(k) K031708

Substantially Equivalent

Osteomed LP

FDA 510(k) clearance K031708 for OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEM, Substantially Equivalent on 2003-11-03. Applicant: Osteomed LP.

Clearance details

Applicant: Osteomed LP
Product code: Code MQN
Advisory panel: Dental
Date received: 2003-06-02
Decision date: 2003-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Addison, TX, US

Download summary PDF View on FDA.gov ↗

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.