KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM— 510(k) K034027

Substantially Equivalent

KLS-Martin L.P.

FDA 510(k) clearance K034027 for KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM, Substantially Equivalent on 2004-02-27. Applicant: KLS-Martin L.P..

Clearance details

Applicant: KLS-Martin L.P.
Product code: Code MQN
Advisory panel: Dental
Date received: 2003-12-29
Decision date: 2004-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, 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.