Cleared Traditional

K050319 - MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104

K050319 is an FDA 510(k) clearance for MAYFIELD MR/CT SKULL CLAMP, manufactured by Integra Lifesciences Corp.. The device is a Class 2 Neurology device with product code HBL cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K050319 · Integra Lifesciences Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
50d
Days
Class 2
Risk

K050319 is an FDA 510(k) clearance for the MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104. Classified as Holder, Head, Neurosurgical (skull Clamp) (product code HBL), Class II - Special Controls.

Submitted by Integra Lifesciences Corp. (Cincinnati, US). The FDA issued a Cleared decision on March 31, 2005 after a review of 50 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 Corp. devices

FDA 510(k) Submission Details - K050319

510(k) Number K050319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2005
Decision Date March 31, 2005
Days to Decision 50 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
98d faster than avg
Panel avg: 148d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K050319.
MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS
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MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
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K051440 · Integra Lifesciences Corp. · Sep 2005
NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX
K031885 · Image-Guided Neurologics, Inc. · Aug 2003
MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
K021604 · Ohio Medical Instrument Co., Inc. · Jul 2002
MIZUHO RADIOLUCENT HEAD FRAME
K955012 · Mizuho America, Inc. · Sep 1996