Cleared Traditional

K993239 - STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX

K993239 is an FDA 510(k) clearance for STRYKER NAVIGATION SYSTEM - NEURO MODULE, manufactured by Stryker Corp.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K993239 · Stryker Corp. · Neurology device
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Jan 2000
Decision
113d
Days
Class 2
Risk

K993239 is an FDA 510(k) clearance for the STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on January 18, 2000 after a review of 113 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 Corp. devices

FDA 510(k) Submission Details - K993239

510(k) Number K993239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1999
Decision Date January 18, 2000
Days to Decision 113 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
35d faster than avg
Panel avg: 148d · This submission: 113d
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 341
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K993239.
SNN STEREOTAXIC PLANNING APPLICATION
K994421 · Surgical Navigation Specialists, Inc. · Feb 2000
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
K992461 · Surgical Navigation Technologies, Inc. · Feb 2000
VOYAGER 6.0 SOFTWARE OPTION
K000310 · Philips Medical Systems (Cleveland), Inc. · Feb 2000
BRAINLAB STEREOTACTIC ARC
K992916 · Brainlab · Jan 2000
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
K992927 · Surgical Navigation Technologies, Inc. · Dec 1999
SNN FLUORO NAVIGATION SYSTEM
K993673 · I.S.G. Technologies, Inc. · Dec 1999