SYNTHES (USA) RATCHETING DISTRACTOR— 510(k) K981275

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K981275 for SYNTHES (USA) RATCHETING DISTRACTOR, Substantially Equivalent on 1998-06-25. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code MQN
Advisory panel: Dental
Date received: 1998-04-08
Decision date: 1998-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paoli, 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.