MENNEN BONE FIXATION DEVICE— 510(k) K892411

Substantially Equivalent

Dentsply Intl.

FDA 510(k) clearance K892411 for MENNEN BONE FIXATION DEVICE, Substantially Equivalent on 1990-01-05. Applicant: Dentsply Intl..

Clearance details

Applicant: Dentsply Intl.
Product code: Code JDQ
Advisory panel: Orthopedic
Date received: 1989-04-07
Decision date: 1990-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

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Adverse events under product code JDQ

product code JDQ

Death: 9
Injury: 330
Total: 339

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.