SYNTHES (USA) (SYNTHES) SINGLE VECTOR DISTRACTOR WITH DETACHABLE FEET— 510(k) K981075

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K981075 for SYNTHES (USA) (SYNTHES) SINGLE VECTOR DISTRACTOR WITH DETACHABLE FEET, Substantially Equivalent on 1998-06-22. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code MQN
Advisory panel: Dental
Date received: 1998-03-24
Decision date: 1998-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paoli, PA, 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.