SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR— 510(k) K981362

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K981362 for SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR, Substantially Equivalent on 1998-06-29. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code DZL
Advisory panel: Dental
Date received: 1998-04-15
Decision date: 1998-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paoli, PA, US

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Adverse events under product code DZL

product code DZL

Injury: 168
Total: 168

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.