STRYKER NAVIGATION SYSTEM-KNEE MODULE— 510(k) K022579

Substantially Equivalent

Stryker Leibinger

FDA 510(k) clearance K022579 for STRYKER NAVIGATION SYSTEM-KNEE MODULE, Substantially Equivalent on 2003-06-02. Applicant: Stryker Leibinger.

Clearance details

Applicant: Stryker Leibinger
Product code: Code HAW
Advisory panel: Neurology
Date received: 2002-08-05
Decision date: 2003-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalamazoo, MI, US

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Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

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.