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

Name: FDA 510(k) clearance K022579
Creator: U.S. Food and Drug Administration
Published: 2003-06-02

Substantially Equivalent

Stryker Leibinger

FDA 510(k) clearance K022579 for STRYKER NAVIGATION SYSTEM-KNEE MODULE, Substantially Equivalent on 2003-06-02. Applicant: Stryker Leibinger. Device class: 2.

Clearance details

Applicant: Stryker Leibinger
Product code: Code HAW
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2002-08-05
Decision date: 2003-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalamazoo, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HAW

view all

K253856 — Geniant Cranial (Navigated Neurosurgical Positioning Robot)2026-09-10
K261932 — Leksell® Vantage Stereotactic System2026-08-05
K253663 — Zeta Navigation System2026-05-01
K253379 — Stealth AXiS Cranial clinical application2026-03-26
K231897 — NeuroAlign software2025-10-21

More clearances from Stryker Leibinger

view all

K052871 — STRYKER CUSTOM TI IMPLANT2005-12-16
K043250 — STRYKER PATIENT SPECIFIC POLYMER IMPLANT2005-04-15
K041651 — STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM2004-09-30
K040022 — STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM2004-03-12
K023449 — NON-INVASIVE PATIENT FIXATION SYSTEM2003-01-13

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.