Cleared Traditional

K981315 - NAVITRACK

K981315 is the FDA 510(k) clearance for NAVITRACK by Orthosoft, Inc.. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K981315 · Orthosoft, Inc. · Neurology device
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Jul 1998
Decision
90d
Days
Class 2
Risk

K981315 is an FDA 510(k) clearance for the NAVITRACK. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Orthosoft, Inc. (Outremont, Quebec, CA). The FDA issued a Cleared decision on July 9, 1998 after a review of 90 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 Orthosoft, Inc. devices

Submission Details

510(k) Number K981315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1998
Decision Date July 09, 1998
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
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 K981315.
VECTORVISION SPINE MODULE
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PHILIPS EASYGUIDE
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WIRELESS STANDARD PROBE, DYNAMIC REFERENCE FRAME (DRF)
K982364 · Radionics, Inc. · Aug 1998
UNIVERSAL INSTRUMENT REGISTRATION (UIR) MICROSCOPE MODULE I
K981213 · Radionics, Inc. · Jul 1998
ATLASPLAN
K980584 · Radionics, Inc. · May 1998
LEKSELL VIEWSCOPE, LEKSELL SURGISCOPE, LEKSELL FREEHAND
K973684 · Elekta Instrument AB · Mar 1998