Cleared Special

K081401 - MAYFIELD MR/X-RAY SKULL CLAMP

K081401 is an FDA 510(k) clearance for MAYFIELD MR/X-RAY SKULL CLAMP, manufactured by Integra Lifesciences Corp.. The device is a Class 2 Neurology device with product code HBL cleared through the Special 510(k) pathway after a 142-day FDA review.

K081401 · Integra Lifesciences Corp. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
142d
Days
Class 2
Risk

K081401 is an FDA 510(k) clearance for the MAYFIELD MR/X-RAY SKULL CLAMP. Classified as Holder, Head, Neurosurgical (skull Clamp) (product code HBL), Class II - Special Controls.

Submitted by Integra Lifesciences Corp. (Planisboro, US). The FDA issued a Cleared decision on October 8, 2008 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4460 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K081401

510(k) Number K081401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2008
Decision Date October 08, 2008
Days to Decision 142 days
Submission Type Special
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
7d faster than avg
Panel avg: 149d · This submission: 142d
Pathway characteristics
Modification to existing cleared device.

HBL Device Classification - Class 2, Special Controls

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 50
Devices cleared under the same product code (HBL) and FDA review panel - the closest regulatory comparables to K081401.
HEAD FIXATION ARC AND TABLE BASE
K091439 · Surgivision, Inc. · Aug 2009
DINKLER SURGICAL SKULL CLAMP, MODEL 0308
K090695 · Dinkler Surgical Devices, Inc. · Apr 2009
MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114
K090506 · Integra LifeSciences Corporation · Apr 2009
LIMITED ARTIFACT SKULL PIN, MODEL 0107
K073163 · Dinkler Surgical Devices, Inc. · Feb 2008
MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS
K072208 · Integra LifeSciences Corporation · Sep 2007
MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS
K071458 · Integra LifeSciences Corporation · Jun 2007
K081401 · MAYFIELD MR/X-RAY SKULL CLAMP
Download PDF FDA Summary Integra Lifesciences …