Cleared Traditional

K063408 - CTLOGICS NAVIGATIONS SYSTEMS

K063408 is the FDA 510(k) clearance for CTLOGICS NAVIGATIONS SYSTEMS by Praxim Medivision, SA. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K063408 · Praxim Medivision, SA · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
107d
Days
Class 2
Risk

K063408 is an FDA 510(k) clearance for the CTLOGICS NAVIGATIONS SYSTEMS. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Praxim Medivision, SA (La Tronche, FR). The FDA issued a Cleared decision on February 28, 2007 after a review of 107 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 Praxim Medivision, SA devices

Submission Details

510(k) Number K063408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2006
Decision Date February 28, 2007
Days to Decision 107 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 148d · This submission: 107d
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 218
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K063408.
DEPUY CAS HEMI ASR HIP INSTRUMENTS
K071334 · DePuy Orthopaedics, Inc. · Jul 2007
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
STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000
K062640 · Stryker Instruments · Dec 2006
VECTORVISION HIP SR
K063028 · Brainlab AG · Dec 2006