Cleared Traditional

K063408 - CTLOGICS NAVIGATIONS SYSTEMS

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

K063408 · Praxim Medivision, SA · Neurology device
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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

FDA 510(k) Submission Details - K063408

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
Combination Product No
PCCP Authorized No
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.

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 349
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K063408.
DEPUY CI HIP INSTRUMENTATION
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K062358 · Brainlab AG · Jan 2007
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K062640 · Stryker Instruments · Dec 2006
VECTORVISION HIP SR
K063028 · Brainlab AG · Dec 2006