OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM— 510(k) K974807

Substantially Equivalent

Osteonics Corp.

FDA 510(k) clearance K974807 for OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM, Substantially Equivalent on 1998-03-16. Applicant: Osteonics Corp..

Clearance details

Applicant: Osteonics Corp.
Product code: Code KWL
Advisory panel: Orthopedic
Date received: 1997-12-23
Decision date: 1998-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

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Adverse events under product code KWL

product code KWL

Injury: 523
Total: 523

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.