SYNTHES CURVILINEAR DISTRACTION SYSTEM— 510(k) K121502

Substantially Equivalent

Synthes, Inc.

FDA 510(k) clearance K121502 for SYNTHES CURVILINEAR DISTRACTION SYSTEM, Substantially Equivalent on 2012-08-23. Applicant: Synthes, Inc..

Clearance details

Applicant: Synthes, Inc.
Product code: Code MQN
Advisory panel: Dental
Date received: 2012-05-21
Decision date: 2012-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, 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.