Cleared Traditional

K062640 - STRYKER NAVIGATION SYSTEM - CRANIAL MODULE

K062640 is the FDA 510(k) clearance for STRYKER NAVIGATION SYSTEM - CRANIAL MODULE by Stryker Instruments. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K062640 · Stryker Instruments · Neurology device
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Dec 2006
Decision
99d
Days
Class 2
Risk

K062640 is an FDA 510(k) clearance for the STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000. 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 December 14, 2006 after a review of 99 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 K062640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2006
Decision Date December 14, 2006
Days to Decision 99 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
49d faster than avg
Panel avg: 148d · This submission: 99d
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 K062640.
DEPUY CI HIP INSTRUMENTATION
K071135 · DePuy Orthopaedics, Inc. · May 2007
VV FLUORO 3D
K070106 · Brainlab AG · Apr 2007
MODIFICATION TO VECTORVISION TRAUMA
K062358 · Brainlab AG · Jan 2007
VECTORVISION HIP SR
K063028 · Brainlab AG · Dec 2006
ZIMMER HIP COMPUTER ASSISTED SOLUTIONS ELECTROMAGNETIC AND IMAGELESS INSTRUMENTATION
K062228 · Zimmer, Inc. · Nov 2006
NAVIVISION
K062086 · Brainlab AG · Sep 2006