STRYKER PEDIATRIC MANDIBLE DISTRACTOR— 510(k) K133398

Substantially Equivalent

Stryker

FDA 510(k) clearance K133398 for STRYKER PEDIATRIC MANDIBLE DISTRACTOR, Substantially Equivalent on 2014-03-20. Applicant: Stryker.

Clearance details

Applicant: Stryker
Product code: Code MQN
Advisory panel: Dental
Date received: 2013-11-06
Decision date: 2014-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portage, MI, 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.