Cleared Traditional

K010361 - MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900

K010361 is an FDA 510(k) clearance for MEDTRONIC PS MEDICAL INVISX CRANIAL FIX..., manufactured by Medtronic PS Medical. The device is a Class 2 Neurology device with product code GXR cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K010361 · Medtronic PS Medical · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
90d
Days
Class 2
Risk

K010361 is an FDA 510(k) clearance for the MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900. Classified as Cover, Burr Hole (product code GXR), Class II - Special Controls.

Submitted by Medtronic PS Medical (Goleta, US). The FDA issued a Cleared decision on May 7, 2001 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5250 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic PS Medical devices

FDA 510(k) Submission Details - K010361

510(k) Number K010361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2001
Decision Date May 07, 2001
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXR Device Classification - Class 2, Special Controls

Product Code GXR Cover, Burr Hole
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5250
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 - GXR Cover, Burr Hole

All 20
Devices cleared under the same product code (GXR) and FDA review panel - the closest regulatory comparables to K010361.
AESCULAP ABSORBABLE CRANIOFIX
K040080 · Aesculap, Inc. · Mar 2004
SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED)
K031654 · Synthes (Usa) · Aug 2003
RESORBABLE CRANIAL CLAMPS
K021408 · Synthes (Usa) · Jul 2002
MACROPORENS CRANILOC
K002334 · Macropore Biosurgery, Inc. · May 2001
BURR HOLE COVER, MODEL XX
K001096 · Image-Guided Neurologics, Inc. · Oct 2000
GORE BURR HOLE COVER
K960656 · W.L. Gore & Associates, Inc. · Aug 1996