MANDIBULAR BONE DISTRACTOR— 510(k) K945674

Substantially Equivalent

Howmedica Corp.

FDA 510(k) clearance K945674 for MANDIBULAR BONE DISTRACTOR, Substantially Equivalent on 1995-06-02. Applicant: Howmedica Corp..

Clearance details

Applicant: Howmedica Corp.
Product code: Code MQN
Advisory panel: Dental
Date received: 1994-11-18
Decision date: 1995-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madrid, ES

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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.