Cleared Traditional

K012380 - MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY

K012380 is an FDA 510(k) clearance for MODIFICATION TO: STRYKER NAVIGATION SYSTEM, manufactured by Stryker Leibinger. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K012380 · Stryker Leibinger · Neurology device
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Dec 2001
Decision
130d
Days
Class 2
Risk

K012380 is an FDA 510(k) clearance for the MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUA.... Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Stryker Leibinger (Kalamazoo, US). The FDA issued a Cleared decision on December 3, 2001 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Leibinger devices

FDA 510(k) Submission Details - K012380

510(k) Number K012380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2001
Decision Date December 03, 2001
Days to Decision 130 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 148d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAW Device Classification - Class 2, Special Controls

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - HAW Neurological Stereotaxic Instrument

All 302
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K012380.
VECTORVISION TRAUMA
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K012938 · Smith & Nephew, Inc. · Feb 2002
MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE
K013861 · Elekta Instrument AB · Dec 2001
HEMI-ARC SURGICAL NAVIGATOR
K013257 · Nuvasive, Inc. · Oct 2001
NAVIGUS II MR
K012719 · Image-Guided Neurologics, Inc. · Oct 2001
NAVIGUS II TRAJECTORY GUIDE
K012366 · Image-Guided Neurologics, Inc. · Oct 2001