Cleared Traditional

K130389 - MAYFIELD INFINITY XR2 SKULL CLAMP (FDA 510(k) Clearance)

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

K130389 · Integra LifeSciences Corporation · Neurology device
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Apr 2013
Decision
67d
Days
Class 2
Risk

K130389 is an FDA 510(k) clearance for the MAYFIELD INFINITY XR2 SKULL CLAMP. Classified as Holder, Head, Neurosurgical (skull Clamp) (product code HBL), Class II - Special Controls.

Submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on April 23, 2013 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4460 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Integra LifeSciences Corporation devices

Submission Details

510(k) Number K130389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2013
Decision Date April 23, 2013
Days to Decision 67 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
81d faster than avg
Panel avg: 148d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HBL Holder, Head, Neurosurgical (skull Clamp)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4460
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.