Cleared Traditional

K981508 - VECTORVISION SPINE MODULE

K981508 is the FDA 510(k) clearance for VECTORVISION SPINE MODULE by Brainlab AG. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K981508 · Brainlab AG · Neurology device
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Oct 1998
Decision
185d
Days
Class 2
Risk

K981508 is an FDA 510(k) clearance for the VECTORVISION SPINE MODULE. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Brainlab AG (Palo Alto, US). The FDA issued a Cleared decision on October 29, 1998 after a review of 185 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. 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 Brainlab AG devices

Submission Details

510(k) Number K981508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1998
Decision Date October 29, 1998
Days to Decision 185 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 148d · This submission: 185d
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 217
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K981508.
NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS
K984245 · Radionics, Inc. · Dec 1998
OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS
K983669 · Radionics, Inc. · Nov 1998
REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAME
K983603 · Radionics, Inc. · Nov 1998
PHILIPS EASYGUIDE
K980820 · Philips Medical Systems, Inc. · Oct 1998
WIRELESS STANDARD PROBE, DYNAMIC REFERENCE FRAME (DRF)
K982364 · Radionics, Inc. · Aug 1998
UNIVERSAL INSTRUMENT REGISTRATION (UIR) MICROSCOPE MODULE I
K981213 · Radionics, Inc. · Jul 1998