Cleared Traditional

K110419 - AVS ARIA NEUROMONITORING PROBE AND AVS ...

K110419 is the FDA 510(k) clearance for AVS ARIA NEUROMONITORING PROBE AND AVS ... by Stryker Spine. It is a Class 2 Neurology device (product code GXZ) cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K110419 · Stryker Spine · Neurology device
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Jul 2011
Decision
164d
Days
Class 2
Risk

K110419 is an FDA 510(k) clearance for the AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS. Classified as Electrode, Needle (product code GXZ), Class II - Special Controls.

Submitted by Stryker Spine (Allendale, US). The FDA issued a Cleared decision on July 28, 2011 after a review of 164 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1350 - 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 Stryker Spine devices

Submission Details

510(k) Number K110419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2011
Decision Date July 28, 2011
Days to Decision 164 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
16d slower than avg
Panel avg: 148d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXZ Electrode, Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1350
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 - GXZ Electrode, Needle

All 13
Devices cleared under the same product code (GXZ) and FDA review panel - the closest regulatory comparables to K110419.
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K933796 · Cadwell Laboratories, Inc. · Dec 1994