MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY— 510(k) K012380

Name: FDA 510(k) clearance K012380
Creator: U.S. Food and Drug Administration
Published: 2001-12-03

Substantially Equivalent

Stryker Leibinger

FDA 510(k) clearance K012380 for MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY, Substantially Equivalent on 2001-12-03. 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: 2001-07-26
Decision date: 2001-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalamazoo, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HAW

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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

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K040022 — STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM2004-03-12
K022579 — STRYKER NAVIGATION SYSTEM-KNEE MODULE2003-06-02

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 →

Recalls naming K012380

K-number listed on FDA's recall record

Z-1216-2018 — The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of the navigation software and creation of a pathway into the pedicle. The instrument has three types of buttons to remotely control the software: the UP, DOWN and SELECT buttons. The Pedicle Feeler is laser marked in 10 mm intervals to help indicate the depth in which the feeler tip has been inserted into the pedicle. Next to the navigational information, these depth indicators on the feeler tip are also helpful in determining the appropriate pedicle screw length.Class II·Terminated·Stryker Instruments Div. of Stryker Corporation·20171016

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K012380.

Data sourced from openFDA. This site is unofficial and independent of the FDA.