Cleared Traditional

K132373 - BIOMET ACCESS SYSTEM (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K132373 · Biomet Spine (Aka Ebi, LLC) · Neurology device
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Mar 2014
Decision
240d
Days
Class 2
Risk

K132373 is an FDA 510(k) clearance for the BIOMET ACCESS SYSTEM. Classified as Neurosurgical Nerve Locator (product code PDQ), Class II - Special Controls.

Submitted by Biomet Spine (Aka Ebi, LLC) (Parsippany, US). The FDA issued a Cleared decision on March 27, 2014 after a review of 240 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 Biomet Spine (Aka Ebi, LLC) devices

Submission Details

510(k) Number K132373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2013
Decision Date March 27, 2014
Days to Decision 240 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
92d slower than avg
Panel avg: 148d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 34
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