Cleared Traditional

K123390 - PEDIGUARD NERVE DETECTOR SYSTEM

K123390 is an FDA 510(k) clearance for PEDIGUARD NERVE DETECTOR SYSTEM, manufactured by Spineguard S.A.. The device is a Class 2 Neurology device with product code PDQ cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K123390 · Spineguard S.A. · Neurology device
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Aug 2013
Decision
279d
Days
Class 2
Risk

K123390 is an FDA 510(k) clearance for the PEDIGUARD NERVE DETECTOR SYSTEM. Classified as Neurosurgical Nerve Locator (product code PDQ), Class II - Special Controls.

Submitted by Spineguard S.A. (Washington, US). The FDA issued a Cleared decision on August 8, 2013 after a review of 279 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 874.1820 - 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 Spineguard S.A. devices

FDA 510(k) Submission Details - K123390

510(k) Number K123390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2012
Decision Date August 08, 2013
Days to Decision 279 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
130d slower than avg
Panel avg: 149d · This submission: 279d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PDQ Device Classification - Class 2, Special Controls

Product Code PDQ Neurosurgical Nerve Locator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1820
Definition To Locate Or Monitor Function Of Spinal Nerve Roots Or Peripheral Nerves During Neurosurgery.
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 - PDQ Neurosurgical Nerve Locator

All 35
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