Cleared Traditional

K003111 - STRYKER NAVIGATION SYSTEM-SPINE & FLUOR...

K003111 is the FDA 510(k) clearance for STRYKER NAVIGATION SYSTEM-SPINE & FLUOR... by Stryker Instruments. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K003111 · Stryker Instruments · Neurology device
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Jan 2001
Decision
92d
Days
Class 2
Risk

K003111 is an FDA 510(k) clearance for the STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on January 4, 2001 after a review of 92 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 Instruments devices

Submission Details

510(k) Number K003111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2000
Decision Date January 04, 2001
Days to Decision 92 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 148d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 217
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K003111.
LORENZ FIDUCAIL SCREW
K010427 · Walter Lorenz Surgical, Inc. · Mar 2001
Z-TOUCH
K003268 · Brainlab AG · Feb 2001
STRYKER REMOTE SURGICAL PLANNING SYSTEM
K004027 · Stryker Instruments · Jan 2001
STRYKER NAVIGATION SYSTEM - ENT MODULE
K002732 · Stryker Corp. · Oct 2000
OPTICAL TRACKING SYSTEM (OTS)
K001950 · Radionics, Inc. · Jul 2000
MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
K001431 · Radionics, Inc. · May 2000