Cleared Special

K062358 - MODIFICATION TO VECTORVISION TRAUMA

K062358 is an FDA 510(k) clearance for MODIFICATION TO VECTORVISION TRAUMA, manufactured by Brainlab AG. The device is a Class 2 Neurology device with product code HAW cleared through the Special 510(k) pathway after a 156-day FDA review.

K062358 · Brainlab AG · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
156d
Days
Class 2
Risk

K062358 is an FDA 510(k) clearance for the MODIFICATION TO VECTORVISION TRAUMA. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Brainlab AG (Feldkirchen, DE). The FDA issued a Cleared decision on January 17, 2007 after a review of 156 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K062358

510(k) Number K062358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2006
Decision Date January 17, 2007
Days to Decision 156 days
Submission Type Special
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
7d slower than avg
Panel avg: 149d · This submission: 156d
Pathway characteristics
Modification to existing cleared device.

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 426
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K062358.
VV FLUORO 3D
K070106 · Brainlab AG · Apr 2007
ARGOS
K061479 · 3D Line Medical Systems S.R.L. · Apr 2007
CTLOGICS NAVIGATIONS SYSTEMS
K063408 · Praxim Medivision, SA · Feb 2007
STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000
K062640 · Stryker Instruments · Dec 2006
VECTORVISION HIP SR
K063028 · Brainlab AG · Dec 2006
ZIMMER HIP COMPUTER ASSISTED SOLUTIONS ELECTROMAGNETIC AND IMAGELESS INSTRUMENTATION
K062228 · Zimmer, Inc. · Nov 2006
K062358 · MODIFICATION TO VECTORVISION TRAUMA
Download PDF FDA Summary Brainlab AG