Cleared Traditional

K062640 - STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000

K062640 is an FDA 510(k) clearance for STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, manufactured by Stryker Instruments. The device is a Class 2 Neurology device with 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

FDA 510(k) Submission Details - K062640

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.

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 331
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