Cleared Traditional

K090506 - MAYFIELD INFINITY XR2 SKULL CLAMP

K090506 is the FDA 510(k) clearance for MAYFIELD INFINITY XR2 SKULL CLAMP by Integra LifeSciences Corporation. It is a Class 2 Neurology device (product code HBL) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K090506 · Integra LifeSciences Corporation · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
54d
Days
Class 2
Risk

K090506 is an FDA 510(k) clearance for the MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114. Classified as Holder, Head, Neurosurgical (skull Clamp) (product code HBL), Class II - Special Controls.

Submitted by Integra LifeSciences Corporation (Cincinnati, US). The FDA issued a Cleared decision on April 20, 2009 after a review of 54 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 K090506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2009
Decision Date April 20, 2009
Days to Decision 54 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
94d faster than avg
Panel avg: 148d · This submission: 54d
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.

Regulatory Peers - HBL Holder, Head, Neurosurgical (skull Clamp)

All 21
Devices cleared under the same product code (HBL) and FDA review panel - the closest regulatory comparables to K090506.
STERILE RADIOLUCENT SKULL PINS
K122225 · Brainlab AG · Apr 2013
MAYFIELD INFINITY XR2 SKULL CLAMP
K130389 · Integra LifeSciences Corporation · Apr 2013
MAYFIELD SKULL CLAMP
K120633 · Integra LifeSciences Corporation · May 2012
MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS
K072208 · Integra LifeSciences Corporation · Sep 2007
MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS
K071458 · Integra LifeSciences Corporation · Jun 2007
MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
K053045 · Integra LifeSciences Corporation · Nov 2005