Cleared Special

K071458 - MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS

K071458 is an FDA 510(k) clearance for MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS, manufactured by Integra LifeSciences Corporation. The device is a Class 2 Neurology device with product code HBL cleared through the Special 510(k) pathway after a 19-day FDA review.

K071458 · Integra LifeSciences Corporation · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
19d
Days
Class 2
Risk

K071458 is an FDA 510(k) clearance for the MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS. 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 June 13, 2007 after a review of 19 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Integra LifeSciences Corporation devices

FDA 510(k) Submission Details - K071458

510(k) Number K071458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2007
Decision Date June 13, 2007
Days to Decision 19 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
129d faster than avg
Panel avg: 148d · This submission: 19d
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 38
Devices cleared under the same product code (HBL) and FDA review panel - the closest regulatory comparables to K071458.
MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114
K090506 · Integra LifeSciences Corporation · Apr 2009
MAYFIELD MR/X-RAY SKULL CLAMP
K081401 · Integra Lifesciences Corp. · Oct 2008
MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS
K072208 · Integra LifeSciences Corporation · Sep 2007
MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
K053045 · Integra LifeSciences Corporation · Nov 2005
MAYFIELD INFINITY SKULL CLAMP
K051440 · Integra Lifesciences Corp. · Sep 2005
MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104
K050319 · Integra Lifesciences Corp. · Mar 2005